Selección de Resúmenes de Menopausia

Semana del 23 al 29 de Mayo 2007

 

Dr. Juan Enrique Blümel

 

 

Clin Obstet Gynecol. 2007 Jun;50(2):354-361

Ovarian Conservation at the Time of Hysterectomy for Benign Disease.

Parker WH, Broder MS, Liu Z, Shoupe D, Farquhar C, Berek JS.

*UCLA School of Medicine double daggerUSC School of Medicine, Los Angeles daggerCerner Health Insights, Beverly Hills parallelStanford School of Medicine, Stanford, California section signUniversity of Auckland School of Medicine, Auckland, New Zealand.

Approximately 78% of women between the ages of 45 and 64 years have prophylactic oophorectomy when hysterectomy is performed for benign disease to prevent the development of ovarian cancer. However, after menopause, the ovary continues to produce androstenedione and testosterone in significant amounts and these androgens are converted in fat, muscle, and skin into estrone. Evidence suggests that oophorectomy increases the subsequent risk of coronary heart disease (CHD) and osteoporosis and whereas 14,000 women die of ovarian cancer every year nearly 490,000 women die of heart disease and 48,000 women die within 1 year after hip fracture. PubMed and the Cochrane database were used to identify studies that examined the incidence of disease and mortality from 5 conditions that seem to be related to ovarian hormones: CHD, ovarian cancer, breast cancer, stroke and hip fracture, and also data for death from all other causes. The data were applied to a Markov decision analytic computer model to calculate risk estimates for mortality from these conditions until the age of 80. The model shows for a hypothetical cohort of 10,000 women undergoing hysterectomy and who chose oophorectomy (vs. ovarian conservation) between the ages of 50 and 54 [without estrogen therapy(ET)], that by the time they reach age 80, 47 fewer women will have died from ovarian cancer, but 838 more women will have died from CHD and 158 more will have died from hip fracture. Therefore, the decision to perform prophylactic oophorectomy should be approached with great caution for the majority of women who are at low risk of developing ovarian cancer.

 

 

J Clin Endocrinol Metab. 2007 May 22; [Epub ahead of print

Ovarian androgen production in postmenopausal women.

Fogle RH, Stanczyk FZ, Zhang X, Paulson RJ.

University of Southern California, Keck School of Medicine, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility.

Context: Several studies previously reported that the postmenopausal ovary produces androgens. However, these findings have recently been questioned in a group of women with adrenal insufficiency. Objective: To utilize contemporary assay methodologies to investigate whether the postmenopausal ovary is hormonally active and contributes to the circulating pool of androgens. Design/Patients: Serum was collected from the ovarian veins of 13 postmenopausal women undergoing total abdominal hysterectomy and bilateral oophorectomy, with sufficient quantities obtained to allow for measurement of several hormones. Serum was also analyzed from peripheral blood collected preoperatively, intraoperatively, and postoperatively. Setting: Los Angeles County Women's and Children's Hospital, University of Southern California Keck School of Medicine Main Outcome Measures: Testosterone (T), androstenedione (A), dehydroepiandrosterone (DHEA), estrone (E1), and estradiol (E2) were measured by radioimmunoassay with preceding organic solvent extraction and Celite column chromatography. Results: Statistically significant gradients were seen between the ovarian venous and peripheral samples for T, A, DHEA, E1, and E2. Postoperative levels of T and E1, but not A, DHEA, or E2, were statistically significantly lower than preoperative levels. A gradient for T between the ovarian venous and peripheral blood was present in 4 of 5 women who were menopausal for more than 10 years. Conclusions: The postmenopausal ovary is hormonally active, contributing significantly to the circulating pool of T. Furthermore, this contribution appears to persist in women as long as 10 years beyond the menopause.

 

 

Metabolism. 2007 Jun;56(6):830-7.

Addition of medroxyprogesterone acetate to conjugated equine estrogens results in insulin resistance in adipose tissue.

Shadoan MK, Kavanagh K, Zhang L, Anthony MS, Wagner JD.

Department of Endocrinology, Lexicon Pharmaceuticals, The Woodlands, TX 77381, USA.

The purpose of this study was to determine if the insulin resistance we have previously reported in surgically postmenopausal primates treated with combined hormone therapy (HT) is due in part to effects on adipose tissue. Eighty-seven ovariectomized monkeys were fed a moderately atherogenic diet (0.28 mg cholesterol per kilocalorie [0.07 mg/kJ]) and randomized to receive no hormones (control, n = 29), estrogen therapy (ET, conjugated equine estrogens, 0.625 mg/d human equivalent; n = 29), or HT (ET + medroxyprogesterone acetate, 2.5 mg/d human equivalent; n = 29) in the diet for 2 years. Fasting glycemic measures were made at baseline and at the end of treatment. Circulating adiponectin measures, insulin tolerance tests, glucose tolerance tests, and isolated adipocyte glucose uptake assays were performed at the end of the trial. Hormone therapy-treated animals were insulin resistant, as determined by greater fasting insulin concentrations (P = .008), greater homeostasis model assessment of insulin resistance (HOMA-R) value (P = .005) and slower glucose disposal after insulin administration (K(ITT); P = .02) when compared with controls. Subcutaneous adipocytes from HT-treated monkeys had a greater ED(50) for insulin (P = .04) and lower maximal glucose uptake per cell (P < .001) compared with controls, suggesting impaired adipocyte insulin sensitivity. Adipocytes were smaller (P = .001) and adiponectin concentrations were greatest in the ET group (P = .02), with no difference between controls and HT-treated monkeys. In conclusion, estrogen therapy resulted in smaller adipocyte size and greater adiponectin concentrations than control or HT. Hormone therapy resulted in impaired insulin sensitivity and adipocyte glucose uptake compared with controls, whereas there was no difference between ET and controls. Because no adverse effects were found with ET alone, it is likely that the progestin, medroxyprogesterone acetate, resulted in the negative effects of the combined HT regimen on whole-body insulin sensitivity, which were mediated, in part, by reductions in adipose tissue responses to insulin.

 

 

Drug Dev Ind Pharm. 2007 Apr;33(4):373-80

Simultaneous Estradiol and Levonorgestrel Transdermal Delivery from a 7-day Patch: In Vitro and In Vivo Drug Deliveries of Three Formulations.

Harrison LI, Zurth C, Gunther C, Karara AH, Melikian A, Lipp R.

3M Drug Delivery Systems. St. Paul, MN. USA.

A new drug-in-adhesive transdermal patch was developed to deliver both estradiol and levonorgestrel through the skin over a 7-day period, but at different rates. This report elucidates the in vitro and in vivo biopharmaceutical studies that were necessary during the development of this product. Three test patches had to be manufactured, all delivering estradiol at the same rate, but delivering levonorgestrel at three different rates so that a levonorgestrel dose response could be studied in the clinic. An in vitro hairless mouse skin model (HMS) using modified Franz diffusion cells was used to select the test products delivering levonorgestrel in the order of 1:2:3. HMS experiments also demonstrated that the presence of estradiol did not affect the flux of levonorgestrel. Two in vivo studies in postmenopausal women showed that at steady state (four weeks of once-weekly dosing) the three test products all delivered estradiol at comparable rates. Similarly, the levonorgestrel deliveries for the three test products were in the order expected. The target fluxes of both drugs were achieved in these three test products by varying the drug loads and patch size. That this approach was successful is evidence of the value of using the HMS penetration experiments in transdermal product development and should provide useful insights for other formulations having to develop complex systems. One of the test products is now marketed as Climara Pro(TM)

 

 

J Chin Med Assoc. 2007 May;70(5):200-6.

A Clinical Trial of 3 Doses of Transdermal 17beta-estradiol for Preventing Postmenopausal Bone Loss: A Preliminary Study.

Yang TS, Chen YJ, Liang WH, Chang CY, Tai LC, Chang SP, Ng HT.

Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, and National Yang-Ming University School of Medicine, Taipei, Taiwan, R.O.C.

Background: It is well documented that a daily oral dose of 0.625 mg of conjugated equine estrogen or 1-2mg of 17beta-estradiol is needed to prevent postmenopausal bone loss. Recent studies have indicated that a lower dose of estrogen maybe as effective in maintaining bone mass. The purpose of this study was to evaluate the effects of 3 dosages of transdermally administered 17beta-estradiol gel in postmenopausal women stratified by oophorectomy and natural menopause. Methods: One hundred and twenty postmenopausal women were randomly selected to form 4 groups. Three groups of women were treated with a transdermal administration of estradiol gel at a daily dosage of 1.25, 2.5 and 5.0 g (containing 0.75, 1.5, and 3 mg of 17beta-estradiol/day), respectively. The 4th group of women, receiving estriol 2 mg/day p.o., was studied concurrently as a control. Bone mineral density was measured by quantitative computed tomography of the vertebrae from T12 to L3 at baseline, then at 6-month intervals for 1 year. Results: Women in all groups receiving 17beta-estradiol gel obtained a significant increase in bone mass, with the exception of the 1.25 g/day group, which showed a minimal increment at the 6-month period, compared with the control group. Comparisons of the increments in bone mass after estrogen therapy for both natural and surgical menopausal subjects found that there was a more prominent response in surgical menopausal women receiving a dosage of 2.5 g/day. Conclusion: Estradiol gel at the dosage of 1.25 g/day, equivalent to 17beta-estradiol 0.75 mg/day, effectively prevented bone loss in postmenopausal women after a 12-month treatment period. The therapeutic effect of estradiol gel on bone mass was more prominent in the surgical menopausal groups at the dosage of 2.5 g/day. The atrophic ovaries may therefore play a crucial role in the subsequent decades of postmenopausal women.

 

 

PLoS Med. 2007 May 22;4(5):e157 [Epub ahead of print] 

Traditional Nonsteroidal Anti-Inflammatory Drugs and Postmenopausal Hormone Therapy: A Drug-Drug Interaction?

Garcia Rodriguez LA, Egan K, Fitzgerald GA.

BACKGROUND: Suppression of prostacyclin (PGI2) is implicated in the cardiovascular hazard from inhibitors of cyclooxygenase (COX)-2. Furthermore, estrogen confers atheroprotection via COX-2-dependent PGI2 in mice, raising the possibility that COX inhibitors may undermine the cardioprotection, suggested by observational studies, of endogenous or exogenous estrogens. METHODS AND FINDINGS: To identify an interaction between hormone therapy (HT) and COX inhibition, we measured a priori the association between concomitant nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, in peri- and postmenopausal women on HT and the incidence of myocardial infarction (MI) in a population-based epidemiological study. The odds ratio (OR) of MI in 1,673 individuals and 7,005 controls was increased from 0.66 (95% confidence interval [CI] 0.50-0.88) when taking HT in the absence of traditional (t)NSAIDs to 1.50 (95% CI 0.85-2.64) when taking the combination of HT and tNSAIDs, resulting in a significant (p < 0.002) interaction. The OR when taking aspirin at doses of 150 mg/d or more was 1.41 (95% CI 0.47-4.22). However, a similar interaction was not observed with other commonly used drugs, including lower doses of aspirin, which target preferentially COX-1. CONCLUSIONS: Whether estrogens confer cardioprotection remains controversial. Such a benefit was observed only in perimenopausal women in the only large randomized trial designed to address this issue. Should such a benefit exist, these results raise the possibility that COX inhibitors may undermine the cardioprotective effects of HT.

 

 

BJOG. 2007 Jun;114(6):664-75

Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis.

van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW.

Department of Gynaecology, Leiden Unviersity Medical Center, Leiden, The Netherlands. H.van_Dongen@lumc.nl

BACKGROUND: This study was conducted to assess the accuracy and feasibility of diagnostic hysteroscopy in the evaluation of intrauterine abnormalities in women with abnormal uterine bleeding. SEARCH STRATEGY: Electronic databases were searched from 1 January 1965 to 1 January 2006 without language selection. The medical subject heading (MeSH) and textwords for the following terms were used: hysteroscopy, diagnosis, histology, histopathology, hysterectomy, biopsy, sensitivity and specificity. SETTING: University Hospital. SELECTION CRITERIA: The inclusion criteria were report on accuracy of diagnostic hysteroscopy in women with abnormal uterine bleeding compared to histology collected with guided biopsy during hysteroscopy, operative hysteroscopy or hysterectomy. DATA COLLECTION AND ANALYSIS: Electronic databases were searched for relevant studies and references were cross-checked. Validity was assessed and data were extracted independently by two authors. Heterogeneity was calculated and data were pooled. Subgroup analysis was performed according to validity criteria, study quality, menopausal state, time, setting and performance of the procedure. The pooled sensitivity, specificity, likelihood ratios, post-test probabilities and feasibility of diagnostic hysteroscopy on the prediction of uterine cavity abnormalities. Post-test probabilities were derived from the likelihood ratios and prevalence of intrauterine abnormalities among included studies. Feasibility included technical success rate and complication rate. MAIN RESULTS: One population of homogeneous data could be identified, consisting of patients with postmenopausal bleeding. In this subgroup the positive and negative likelihood ratios were 7.9 (95% CI 4.79-13.10) and 0.04 (95% CI 0.02-0.09), raising the pre-test probability from 0.61 to a post-test probability of 0.93 (95% CI 0.88-0.95) for positive results and reducing it to 0.06 (95% CI 0.03-0.13) for negative results. The pooled likelihood ratios of all studies included, calculated with the random effects model, were 6.5 (95% CI 4.1-10.4) and 0.08 (95% CI 0.07-0.10), changing the pre-test probability of 0.46 to post-test probabilities of 0.85 (95% CI 0.78-0.90) and 0.07 (0.06-0.08) for positive and negative results respectively. Subgroup analyses gave similar results. The overall success rate of diagnostic hysteroscopy was estimated at 96.9% (SD 5.2%, range 83-100%). CONCLUSIONS: This systematic review and meta-analysis shows that diagnostic hysteroscopy is both accurate and feasible in the diagnosis of intrauterine abnormalities.

 

 

Int J Cancer. 2007 May 22; [Epub ahead of print

IGF-I and mammographic density in four geographic locations: A pooled analysis.

Maskarinec G, Takata Y, Chen Z, Gram IT, Nagata C, Pagano I, Hayashi K, Arendell L, Skeie G, Rinaldi S, Kaaks R.

Cancer Research Center, University of Hawaii.

Insulin-like growth factor (IGF-I) and prolactin have been found to be associated with breast cancer risk and with mammographic density. In a pooled analysis from 4 geographic locations, we investigated the association of percent mammographic density with serum levels of IGF-I, IGFBP-3 and prolactin. The pooled data set included 1,327 pre- and postmenopausal women: Caucasians from Norway, Arizona and Hawaii, Japanese from Hawaii and Japan, Latina from Arizona, and Native Hawaiians from Hawaii. Serum samples were assayed for IGF-I, IGFBP-3 and prolactin levels using ELISA assays. Mammographic density was quantified using a computer-assisted density method. After stratification by menopausal status, multiple regression models estimated the relation between serum analytes and breast density. All serum analytes except prolactin among postmenopausal women differed significantly by location/ethnicity group. Among premenopausal subjects, IGF-I levels and the molar ratio were highest in Hawaii, intermediate in Japan and lowest in Arizona. For IGFBP-3, the order was reversed. Among postmenopausal subjects, Norwegian women had the highest IGF-I levels and women in Arizona had the lowest while women in Japan and Hawaii had intermediate levels. We observed no significant relation between percent density and IGF-I or prolactin levels among pre-and postmenopausal women. The significant differences in IGF-I levels by location but not ethnicity suggest that environmental factors influence IGF-I levels, whereas percent breast density varies more according to ethnic background than by location. Based on this analysis, the influence of circulating levels of IGF-I, IGFBP-3, and prolactin on percent density appears to be very small.

 

 

Lancet. 2007 May 19;369(9574):1703-10

Ovarian cancer and hormone replacement therapy in the Million Women Study.

Beral V; Million Women Study Collaborators; Bull D, Green J, Reeves G.

Million Women Study Coordinating Centre, Cancer Research UK Epidemiology Unit, Richard Doll Building, Roosevelt Drive, Oxford, OX3 7LF, UK. pa.valerie.beral@ceu.ox.ac.uk

BACKGROUND: Ovarian cancer is the fourth most common cancer in women in the UK, with about 6700 developing the malignancy and 4600 dying from it every year. However, there is limited information about the risk of ovarian cancer associated with the use of hormone replacement therapy (HRT). METHODS: 948,576 postmenopausal women from the UK Million Women Study who did not have previous cancer or bilateral oophorectomy were followed-up for an average of 5.3 years for incident ovarian cancer and 6.9 years for death. Information on HRT use was obtained at recruitment and updated where possible. Relative risks for ovarian cancer were calculated, stratified by age and hysterectomy status, and adjusted by area of residence, socioeconomic group, time since menopause, parity, body-mass index, alcohol consumption, and use of oral contraceptives. FINDINGS: When they last reported HRT use, 287,143 women (30%) were current users and 186 751 (20%) were past users. During follow-up, 2273 incident ovarian cancers and 1591 deaths from the malignancy were recorded. Current users were significantly more likely to develop and die from ovarian cancer than never users (relative risk 1.20 [95% CI 1.09-1.32; p=0.0002] for incident disease and 1.23 [1.09-1.38; p=0.0006] for death). For current users of HRT, incidence of ovarian cancer increased with increasing duration of use, but did not differ significantly by type of preparation used, its constituents, or mode of administration. Risks associated with HRT varied significantly according to tumour histology (p<0.0001), and in women with epithelial tumours the relative risk for current versus never use of HRT was greater for serous than for mucinous, endometroid, or clear cell tumours (1.53 [1.31-1.79], 0.72 [0.52-1.00], 1.05 [0.77-1.43], or 0.77 [0.48-1.23], respectively). Past users of HRT were not at an increased risk of ovarian cancer (0.98 [0.88-1.11] and 0.97 [0.84-1.11], respectively, for incident and fatal disease). Over 5 years, the standardised incidence rates for ovarian cancer in current and never users of HRT were 2.6 (2.4-2.9) and 2.2 (2.1-2.3) per 1000, respectively-ie, one extra ovarian cancer in roughly 2500 users; death rates were 1.6 (1.4-1.8) and 1.3 (1.2-1.4) per 1000, respectively-ie, one extra ovarian cancer death in roughly 3300 users. INTERPRETATION: Women who use HRT are at an increased risk of both incident and fatal ovarian cancer. Since 1991, use of HRT has resulted in some 1300 additional ovarian cancers and 1000 additional deaths from the malignancy in the UK.

 

 

Georgian Med News. 2007 Apr;(145):52-5.

Effect of metformin therapy on plasma adiponectin and leptin levels in obese and insulin resistant postmenopausal females with type 2 diabetes.

Adamia N, Virsaladze D, Charkviani N, Skhirtladze M, Khutsishvili M.

Department of Endocrinology, Tbilisi State Medical University.

To investigate the relative role of the adiponectin and leptin in the insulin resistance (IR) and obesity we studied plasma levels of these adipocytokines in obese and insulin resistant postmenopausal (PM) females with type 2 diabetes (DM2) during 6 months of Metformin therapy. We recruited 26 PM women, between the ages of 50 and 67 (59,7+/-8,1 years). These women had a BMI of 36,6+/-1,8 kg/m(2). After baseline measurements Metformin therapy has been initiated (1700+/-2550 mg per day). Duration of therapy was 6 months. The results of investigations of adipocytokines after Metformin 6 months therapy shown that circulating adiponectin levels were significantly increased (19,1+/-6,0 vs. 16,1+/-3,9 ng/ml, p=0,008) together with significant reduction of BMI (35,9+/-1,9 vs. 36,6+/-1,8 kg/m(2), p=0,005) and IR (3,05+/-0,89 vs. 3,96+/-0,70, p<0,001). The magnitude of the change in adiponectin levels positively correlated with the magnitude of BMI reduction (r=0,4784, p=0,013) and IR reduction (r=0,5779, p=0,002). Any significant correlation did not observed between changes of leptin levels and BMI, leptin levels and IR. In summary, our data suggest that hypoadiponectinemia in PM may be explained by only IR because the amelioration of whole-body insulin action by 6-month Metformin therapy leads to increase of plasma adiponectin levels; leptin levels did not significantly change after 6-month Metformin therapy.

Semana del 15 al 22 de Mayo 2007

 

Dr. Juan Enrique Blümel

 

 

Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):900-5

Usual physical activity and endogenous sex hormones in postmenopausal women: the European prospective investigation into cancer-norfolk population study.

Chan MF, Dowsett M, Folkerd E, Bingham S, Wareham N, Luben R, Welch A, Khaw KT.

Clinical Gerontology Unit Box 251, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Cambridge CB2 2QQ, United Kingdom. kk101@medschl.cam.ac.uk.

BACKGROUND: Short-term trials indicate that intensive physical activity may influence endogenous sex hormone concentrations. However, the relationship between usual daily physical activity and endogenous hormones in postmenopausal women in the general population is still uncertain. Objective and METHODS: To determine the relationship between usual physical activity and endogenous sex hormones in postmenopausal women. A cross-sectional population-based study of 2,082 postmenopausal women ages 55 to 81 years, residing in the general community of Norfolk, United Kingdom, and not currently using hormone replacement therapy were chosen to participate. Physical activity in the past 1 year was assessed using a validated questionnaire, and endogenous sex hormone and sex hormone-binding globulin (SHBG) concentrations were determined. RESULTS: Usual physical activity levels were inversely associated with circulating concentrations of testosterone and estradiol, testosterone/SHBG ratio, and positively associated with SHBG. These associations were only slightly attenuated after adjusting for potential covariates including body mass index, smoking status, alcohol intake, and reproductive variables. Testosterone concentrations and testosterone/SHBG ratios were 19% [95% confidence interval (95% CI), 9-27%, P < 0.001] and 24.0% (95% CI, 13-34% P < 0.001) lower, respectively, whereas estradiol concentrations were 6% (95% CI, 0-12%; P < 0.05) lower in the highest compared with lowest activity levels, respectively. A decreasing trend for the estradiol/SHBG ratio and 17alpha-hydroxyprogesterone concentrations was also observed. Androstenedione levels did not differ significantly according to physical activity. CONCLUSIONS: Higher usual physical activity levels among postmenopausal women seem to be related to lower endogenous testosterone and estradiol concentrations. This may be one mechanism that could partly explain the reported inverse relationship between physical activity and breast cancer risk in some studies.

 

 

Cancer Epidemiol Biomarkers Prev. 2007 May;16(5):921-8

Longitudinal trends in mammographic percent density and breast cancer risk.

Vachon CM, Pankratz VS, Scott CG, Maloney SD, Ghosh K, Brandt KR, Milanese T, et al.

Mayo Clinic College of Medicine, Charlton 6-239, 200 First Street Southwest, Rochester, MN 55905.

BACKGROUND: Mammographic density is a strong risk factor for breast cancer. However, whether changes in mammographic density are associated with risk remains unclear. MATERIALS AND METHODS: A study of 372 incident breast cancer cases and 713 matched controls was conducted within the Mayo Clinic mammography screening practice. Controls were matched on age, exam date, residence, menopause, interval between, and number of mammograms. All serial craniocaudal mammograms 10 years before ascertainment were digitized, and quantitative measures of percent density (PD) were estimated using a thresholding method. Data on potential confounders were abstracted from medical records. Logistic regression models with generalized estimating equations were used to evaluate the interactions among PD at earliest mammogram, time from earliest to each serial mammogram, and absolute change in PD between the earliest and subsequent mammograms. Analyses were done separately for PD measures from the ipsilateral and contralateral breast and also by use of hormone therapy (HT). RESULTS: Subjects had an average of five mammograms available, were primarily postmenopausal (83%), and averaged 61 years at the earliest mammogram. Mean PD at earliest mammogram was higher for cases (31%) than controls (27%; ipsilateral side). There was no evidence of an association between change in PD and breast cancer risk by time. Compared with no change, an overall reduction of 10% PD (lowest quartile of change) was associated with an odds ratio of 0.9997 and an increase of 6.5% PD (highest quartile of change) with an odds ratio of 1.002. The same results held within the group of 220 cases and 340 controls never using HT. Among the 124 cases and 337 controls known to use HT during the interval, there was a statistically significant interaction between change in PD and time since the earliest mammogram (P = 0.01). However, in all groups, the risk associated with the earliest PD remained a stronger predictor of risk than change in PD. CONCLUSION: We observed no association between change in PD with breast cancer risk among all women and those never using HT. However, the interaction between change in PD and time should be evaluated in other populations.

 

 

Menopause. 2007 May 15; [Epub ahead of print

Symptoms, menopause status, and country differences: a comparative analysis from DAMES.

Obermeyer CM, Reher D, Saliba M.

Department of Population and International Health, Harvard University, Boston, MA.

OBJECTIVE:: To investigate reported frequencies of menopausal symptoms among women in four countries, namely Lebanon, Morocco, Spain, and the United States, and to assess the relative role of menopause status, country of residence, and other factors in explaining differences in symptomatology. DESIGN:: Surveys of representative samples of approximately 300 women aged 45 to 55 years in each site were conducted, using an instrument that includes demographic, health, and menopausal variables, in addition to perceptions and attitudes toward menopause. Statistical and textual analyses are used to examine differentials and the factors that influence them. RESULTS:: The burden of symptoms and the frequencies of symptoms differ across sites, but hot flashes are reported everywhere by just under one half of the respondents. The most frequent symptoms are joint pain, fatigue, impatience/nervousness, sleep disturbances, memory loss, and one or more emotional symptoms. Menopause status is significantly associated with hot flashes and vasomotor symptoms and to a lesser extent with emotional and sexual symptoms. Smoking, schooling, employment, and age are also associated with the frequency of selected symptoms. Country of residence influences reported symptoms over and above other factors. CONCLUSIONS:: Similarities among core symptoms and differences in the expression of symptoms were found across sites. Both biological (menopause status) and cultural (country of residence) variables influence symptomatology.

 

 

J Clin Lab Anal. 2007 May 16;21(3):197-200 [Epub ahead of print

Relationship of serum adiponectin with blood lipids, HbA(1)c, and hs-CRP in type II diabetic postmenopausal women.

Goodarzi MT, Babaahmadi-Rezaei H, Kadkhodaei-Eliaderani M, Haddadinezhad S.

Department of Biochemistry & Nutrition, Medical School, Hamadan University, Hamadan, Iran.

Adipose tissue has been considered an important endocrine organ. Adiponectin secretes from adipose tissue and plays an important role in the regulation of glycemia, beta-oxidation in muscle, and decreased insulin resistance in the liver. The objectives of this study were to compare the levels of adiponectin, hs-C-reactive protein (CRP), HbA1c, and blood lipids among diabetic and healthy postmenopausal women, and to determine the relationship between circulating adiponectin and development of type II diabetes. This case-control study was performed on 28 diabetic and 42 age-matched healthy women. All participants were postmenopausal. Serum adiponectin concentrations, serum triglycerides (TG), cholesterol, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) concentrations were determined. Blood HbA1c and serum hs-CRP were also measured. Adiponectin levels were significantly decreased (P<0.01) in the diabetic patients as compared to normal control subjects. Adiponectin levels were negatively associated with hs-CRP, LDL-C, HbA1c, TG, and total cholesterol (TC). A positive correlation was observed between adiponectin and HDL-C. The obtained data indicate that diabetic women have lower adiponectin levels compared to healthy women. HbA1c as an indicator of glycemic control has a negative correlation with serum adiponectin. Adiponectin may play an important role in the pathogenesis of diabetes, and may be an independent predictor of the development of diabetes in women.

 

 

J Endocrinol Invest. 2007 Mar;30(3):230-5

Favorable clinical heart and bone effects of anti-thyroid drug therapy in endogenous subclinical hyperthyroidism.

Buscemi S, Verga S, Cottone S, Andronico G, D'Orio L, Mannino V, Panzavecchia D, Vitale F, Cerasola

Department of Internal Medicine, Cardiovascular and Kidney Diseases, University of Palermo, Palermo.

Although subclinical hyperthyroidism (SCH) has been associated with increased risk of osteoporosis and cardiac arrhythmias, its treatment is still controversial. This study was designed as a prospective, randomized, intervention, control-study with a 1-year follow-up in order to investigate whether normalization of serum TSH in SCH using methimazole has favorable bone and heart clinical effects. Fourteen patients with endogenous SCH (not Graves' disease) were enrolled, 7 (5 women/2 men; group T) were treated with methimazole (2.5-7.5 mg/day), and 7 (5 women/2 men; group C) were followed without treatment; 10 healthy subjects were also included in the study as controls. Serum free-T3 (FT3), free-T4 (FT4) and TSH, thyroid echography, bone stiffness index (SI), as measured by heel ultrasonometry, and 24-h electrocardiography monitoring were obtained. SCH patients exhibited higher systolic and diastolic blood pressure than control subjects. They also had a significantly higher number of both ventricular premature beats (VPB) (mean+/-SEM: 681+/-238 vs 6+/-2 beats/24 h; p<0.02) and atrial premature beats (APB) (mean+/-SEM: 495+/-331 vs 7+/-2 beats/24 h; p<0.0001), and a lower SI (66+/-5 vs 96+/-3; p<0.001). Twelve months after normalization of TSH with the use of methimazole, the number of VPB decreased significantly (947+/-443 vs 214+/-109 beats/24 h; p<0.05) while it remained unchanged in untreated SCH patients (414+/-163 vs 487+/-152 beats/24 h; p=ns). An insignificant therapy effect was observed as far as APB were concerned (826+/-660 vs 144+/-75 beats/24 h; p=ns), however their number increased significantly in the untreated group (463+/-49 vs 215+/-46 beats/24 h; p<0.05). The SI increased significantly as a result of therapy in group T (64.1+/-4.8 vs 70.0+/-5.3; p<0.02) and was further reduced in group C at the end of the study (69.1+/-7.3 vs 62.9+/-7.1; p<0.001). No adverse effect was observed in group T. In conclusion, anti-thyroid therapy seems to have favor-able bone and heart clinical effects in subjects with endogenous SCH.

 

 

Int J Clin Pract. 2007 Jun;61(6):963-71

Is treatment of early postmenopausal women with bisphosphonates justified?

Epstein S.

Mount Sinai School of Medicine, New York, NY, USA, and Doylestown Hospital, Doylestown, PA.

The decision to treat women in the early postmenopausal period has come under scrutiny because of the low occurrence of fractures in this population and the possible lack of cost-effectiveness for individual patients. This article focuses on the potential use of bisphosphonates for the prevention and treatment of osteoporosis in the early postmenopausal period. Studies have determined that there is a relationship between bisphosphonate treatment and bone mineral density (BMD) gains, even in women in the early postmenopausal period without a diagnosis of osteoporosis. These patients receive benefit from treatment, including improvements in BMD levels and fracture protection. Using BMD scores, rates of bone turnover, and risk-based diagnostic criteria as part of the decision to initiate therapy may allow for the identification of an early postmenopausal patient population that would benefit from preventative therapy. This would improve the cost-effectiveness of using bisphosphonates for the prevention of osteoporosis in this population. The evaluation of women at risk for developing osteoporosis should include an assessment of both BMD scores and additional risk factors. Early postmenopausal women who are in a high-risk group should be considered candidates to receive bisphosphonate therapy.

 

 

Drugs Aging. 2007;24(5):361-79

Selective estrogen receptor modulators for postmenopausal osteoporosis : current state of development.

Gennari L, Merlotti D, Valleggi F, Martini G, Nuti R.

Department Internal Medicine, Endocrine-Metabolic Sciences & Biochemistry, University of Siena, Italy.

Selective estrogen receptor modulators (SERMs) are structurally different compounds that interact with intracellular estrogen receptors in target organs as estrogen receptor agonists and antagonists. These drugs have been intensively studied over the past decade and have proven to be a highly versatile group for the treatment of different conditions associated with aging, including hormone-responsive cancer and osteoporosis. Tamoxifen and toremifene are currently used to treat advanced breast cancer and also have beneficial effects on bone mineral density and serum lipids in postmenopausal women. Raloxifene is the only SERM approved worldwide for the prevention and treatment of postmenopausal osteoporosis and vertebral fractures. However, although these SERMs have many benefits, they may also be responsible for some potentially very serious adverse effects, such as thromboembolic disorders and, in the case of tamoxifen, uterine cancer. These adverse effects represent a major concern given that long-term therapy is required to prevent osteoporosis. Moreover, both preclinical and clinical reports suggest that tamoxifen, toremifene and raloxifene are considerably less potent than estrogen.The search for the 'ideal' SERM, which would have estrogenic effects on bone and serum lipids, neutral effects on the uterus, and antiestrogenic effects on breast tissue, but none of the adverse effects associated with current therapies, is currently under way. Ospemifene, lasofoxifene, bazedoxifene and arzoxifene, which are new SERM molecules with potential greater efficacy and potency than previous SERMs, are currently under investigation for use in the treatment and prevention of osteoporosis. These drugs have been shown to be comparably effective to conventional hormone replacement therapy in animal models of osteoporosis, with potential indications for an improved safety profile. Clinical efficacy data from ongoing phase III trials are awaited so that a true understanding of the therapeutic potential of these compounds can be obtained.

 

 

Drugs Aging. 2007;24(5):351-9

Intermittent bisphosphonate therapy in postmenopausal osteoporosis: progress to date.

Reginster JY, Malaise O, Neuprez A, Jouret VE, Close P.

Department of Public Health, Epidemiology and Health Economics, University of Liege, Liege, Belgium.

Bisphosphonates are the most widely prescribed drugs in osteoporosis today. They have unequivocally shown their ability to reduce fracture rate at the spine (alendronic acid, risedronic acid, ibandronic acid) and at the hip (alendronic acid and risedronic acid). However, their dosage and administration procedures and the adverse reactions induced by their oral intake are responsible for low adherence. Therefore, intermittent regimens have been developed. Weekly alendronic acid and risedronic acid provide similar benefits, in terms of bone mineral density (BMD) and changes in biochemical markers, as those seen with their daily formulations. Ibandronic acid has been shown to reduce vertebral fractures when given intermittently. Ibandronic acid given orally monthly and intravenously every 2 or 3 months provides increases in BMD similar to the daily formulation. Yearly intravenous infusions of zoledronic acid are currently being evaluated for their ability to reduce fractures. If the efficacy and safety of bisphosphonates given at administration intervals longer than weekly are confirmed, this might significantly improve patient adherence and long-term outcomes of bisphosphonate treatment in postmenopausal osteoporosis.

 

 

Menopause. 2007 May 11; [Epub ahead of print

Hormone therapy and coronary heart disease in young women.

Weiner MG, Barnhart K, Xie D, Tannen RL.

Departments of Medicine, Obstetrics and Gynecology, and Clinical Epidemiology and Biostatistics, and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA.

OBJECTIVE:: Because the Women's Health Initiative randomized controlled trial (WHI RCT) primarily studied older women, it is unresolved whether hormone therapy might prevent coronary heart disease in younger women. Given the similarity between our UK General Practice Research Database (GPRD) study of older women and the WHI RCT, the GPRD methodology was used to study a cohort of younger women. DESIGN:: Women ages 50 to 55 years were investigated using data from the GPRD to simulate the WHI RCT in a manner similar to our initial study of older women. This study compared 30,102 unexposed and 20,654 exposed women treated with conjugated estrogens and norgestrel. RESULTS:: Myocardial infarction was not altered significantly by hormone therapy (adjusted hazard ratio 0.91; 95% CI, 0.69-1.20). Stroke, venous thromboembolic events, breast cancer, and hip fracture were similar to both the GPRD study of older women and the WHI RCT. Although death was decreased in the total cohort, similar to older women, it was not altered significantly in a subset without missing covariate data. CONCLUSION:: The similar results of the GPRD studies in younger and older women and between the GPRD and the WHI RCT suggest that hormone therapy does not prevent coronary heart disease in younger postmenopausal women. This study also demonstrates that investigation using a primary care electronic medical record database can expand the generalizability of findings from an RCT.

 

 

Arch Intern Med. 2007 May 14;167(9):893-902

Calcium plus vitamin d supplementation and the risk of postmenopausal weight gain.

Caan B, Neuhouser M, Aragaki A, Lewis CB, Jackson R, Leboff MS, Margolis KL, Powell L, et al.

Division of Research, Kaiser Permanente Northern California, Oakland.

BACKGROUND: Obesity in the United States has increased significantly during the past several decades. The role of calcium in the maintenance of a healthy body weight remains controversial. METHODS: A randomized, double-blinded, placebo-controlled trial was performed with 36 282 postmenopausal women, aged 50 to 79 years, who were already enrolled in the dietary modification and/or hormone therapy arms of the Women's Health Initiative clinical trial. Women were randomized at their first or second annual visit to receive a dose of 1000 mg of elemental calcium plus 400 IU of cholecalciferol (vitamin D) or placebo daily. Change in body weight was ascertained annually for an average of 7 years. RESULTS: Women receiving calcium plus cholecalciferol supplements vs women receiving placebo had a minimal but consistent favorable difference in weight change (mean difference, -0.13 kg; 95% confidence interval, -0.21 to -0.05; P = .001). After 3 years of follow-up, women with daily calcium intakes less than 1200 mg at baseline who were randomized to supplements were 11% less likely to experience small weight gains (1-3 kg) and 11% less likely to gain more moderate amounts of weight (>3 kg) (P for interaction for baseline calcium intake = .008). CONCLUSION: Calcium plus cholecalciferol supplementation has a small effect on the prevention of weight gain, which was observed primarily in women who reported inadequate calcium intakes.

 

 

Bone. 2007 Apr 4; [Epub ahead of print

Is short vertebral height always an osteoporotic fracture? The Osteoporosis and Ultrasound Study (OPUS).

Ferrar L, Jiang G, Armbrecht G, Reid DM, Roux C, Gluer CC, Felsenberg D, Eastell R.

Unit of Bone Metabolism, Division of Clinical Sciences, University of Sheffield, Sheffield, UK.

INTRODUCTION AND HYPOTHESIS:: Diagnosis of prevalent osteoporotic vertebral fracture is complicated by normal or developmental variation in vertebral shape or size and non-osteoporotic deformities that appear to have 'reduced' height. Using our visual approach, the algorithm-based qualitative method (ABQ) a vertebra with apparent "reduced" height without evidence of osteoporotic endplate depression is classified as non-osteoporotic short vertebral height (SVH). We aimed to determine whether ABQ classification of SVH represents true or false negative diagnosis of osteoporotic vertebral fracture, by testing the associations with clinical outcomes of osteoporosis or vertebral fracture. METHODS:: The ABQ method was used to assess spinal radiographs acquired at baseline for a subset of 904 postmenopausal women participating in the Osteoporosis and Ultrasound Study (OPUS). The sample was enriched with vertebral fracture cases. Subjects were categorized by ABQ diagnosis as (i) normal, (ii) non-osteoporotic short vertebral height (SVH) or (iii) osteoporotic vertebral fracture. RESULTS:: Women were classified by ABQ as follows: osteoporotic vertebral fracture, n=231; SVH, n=376 and normal, n=297. Women with vertebral fracture were older, with lower height, weight and height loss than those classified as SVH or normal. Women with SVH were heavier and older, with greater historical height loss than normal women. Age-adjusted SD units (z-scores) for BMD were lower than expected among women with osteoporotic vertebral fracture, but not among those with SVH. There was a significant association between diagnosis of osteoporotic vertebral fracture and history of low-trauma non-vertebral and vertebral fracture (p<0.001, odds ratios=3.2 and 20.6, respectively). There was also an association between diagnosis of SVH and previous low-trauma non-vertebral fracture (p<0.05, odds ratio=1.7). CONCLUSIONS:: Short vertebral height without evidence of central endplate fracture in postmenopausal women is largely unrelated to osteoporosis. Quantitative morphometry should not be used alone for the assessment of vertebral fracture in clinical decision making: we recommend differential diagnosis of morphometric vertebral deformities by an expert reader to rule out non-osteoporotic deformities with short vertebral height.

 

 

Diabetes Metab. 2007 May 10; [Epub ahead of print

Relationship between the hyperinsulinemic-euglycaemic clamp and a new simple index assessing insulin sensitivity in overweight and obese postmenopausal women.

Bastard JP, Vandernotte JM, Faraj M, Karelis AD, Messier L, Malita FM, Garrel D, et al.

Service de biochimie et hormonologie, hopital Tenon, APHP, 75020 Paris, France..

OBJECTIVE: The purpose of this study was to compare assessment of insulin sensitivity from hyperinsulinemic euglycaemic (HIEG) clamp with indexes derived from fasting and oral glucose tolerance test (OGTT). SUBJECTS AND METHODS: Cross-sectional study with 107 sedentary non-diabetic overweight and obese postmenopausal (BMI=32.4+/-0.4 kg/m(2)) women undergoing both HIEG clamp and OGTT. Pairs of data were analyzed using Pearson correlation and Bland-Altman graphs analysis. Comparison between correlations was made using the method reported by Zar. RESULTS: All the indexes derived from either the OGTT or surrogate indexes were highly correlated with all the clamp-derived formulas (P<0.0001). However, HOMA and QUICKI were generally less correlated than OGTT-derived indexes. Analogically to QUICKI, we calculated a new formula derived from the OGTT measurements of glucose and insulin named simple index assessing insulin sensitivity (SI(is)OGTT)=1/[log(sum glucose t(0-30-90-120)) (mmol/l)+log(sum insulin t(0-30-90-120)) (muUI/ml)]. By using this formula, we found high significant correlations (r's=0.61-0.65; P<0.0001) with the clamp results. Moreover, the correlations of SI(is)OGTT with the clamp data were higher than for other previously published indexes. CONCLUSION: In that large group of non-diabetic overweight and obese postmenopausal women insulin sensitivity index derived from OGTT provided more accurate information than fasting based formula. We propose a new simple index for the assessment of insulin sensitivity from the OGTT data (SI(is)OGTT). The advantage of this new formula over all previously published OGTT-derived indexes of insulin sensitivity is that it is 1) easy to calculate 2) better correlated than other indexes of insulin sensitivity and 3) not affected by the way clamp results are expressed. Further studies are needed to validate SI(is)OGTT index in other populations.

 

 

J Bone Miner Res. 2007 May 14; [Epub ahead of print

Osteoporosis in Patients with Diabetes Mellitus.

Hofbauer LC, Brueck CC, Singh SK, Dobnig H.

Microabstract Demographic trends with longer life expectancy and a lifestyle characterized by low physical activity and high-energy food intake contribute to an increasing incidence of diabetes mellitus and osteoporosis. Diabetes mellitus is a risk factor for osteoporotic fractures. Patients with recent onset of type 1 diabetes mellitus may have impaired bone formation due to the absence of the anabolic effects of insulin and amylin, while in long-standing type 1 diabetes mellitus, vascular complications may account for low bone mass and increased fracture risk. Patients with type 2 diabetes mellitus display an increased fracture risk despite a higher BMD which is mainly attributable to the increased risk of falling. Strategies to improve BMD and to prevent osteoporotic fractures in patients with type 1 diabetes mellitus may include optimal glycemic control and aggressive prevention and treatment of vascular complications. Patients with type 2 diabetes mellitus may additionally benefit from early visual assessment, regular exercise to improve muscle strength and balance, and specific measures for preventing falls.

 

 

Bone. 2007 Apr 10; [Epub ahead of print

Transmenopausal changes in the trabecular bone structure.

Akhter MP, Lappe JM, Davies KM, Recker RR.

Osteoporosis Research Center, Creighton University,  Omaha, NE 68131, USA.

INTRODUCTION: Post-menopausal osteoporosis is a disorder of excess skeletal fragility, due partly to changes in bone microstructure. Menopause is known to result in bone loss and reduction in bone mechanical strength. However, the mechanism and nature of microstructural changes at menopause need more detailed description and analyses. The overall hypothesis for this analysis is that the variables describing trabecular bone micro-architecture will be affected by changes in the hormonal status of women just prior to, and early after, last menses, and that volumetric bone density, and trabecular structure will decline significantly. The study was designed to capture true longitudinal transmenopausal changes in three-dimensional (3-D) trabecular bone architecture. Currently, minimal data exist regarding these features. MATERIALS AND METHODS: Transilial biopsies specimens were obtained from healthy pre-menopausal women (age >46), and repeated at 12 months after the last menstrual period. Bone architecture was quantified in 38 paired specimens using micro-computed tomography (micro-CT-40, Scanco) techniques. Bone biopsies were embedded for histomorphomteric analyses and parts of the analyses have been published elsewhere. Embedded bone biopsies were scanned at 30-mum resolution such that the region of interest was similar to that in the two-dimensional (2-D) histomorphometric analyses. Paired t-tests were used to compare the pre- and post-menopausal bone structural data from each technique. RESULTS: There was good correlation between standard histomorphometric (2-D) and micro-CT (3-D) measurements. Most of the variables characterizing bone structure in post-menopausal women (from micro-CT) significantly decreased (BV/TV, trabecular number, apparent and tissue density). In addition, both trabecular spacing (Tb.S) and the structure model index (SMI) increased in the post-menopausal women suggesting transformation of trabecular bone from plate- to rod-like structure. The 3-D trabecular connectivity density (Conn.D) was negatively correlated with activation frequency (Ac.f). CONCLUSIONS: These data suggest that 3-D micro-CT measurements (longitudinal) are comparable to those of standard histomorphometry, and that most of the bone structural measurements are sensitive to changes in women's hormonal status across menopause.

 

 

Semana del 8 al 14 de Mayo 2007

 

Dr. Juan Enrique Blümel

 

Fertil Steril. 2007 May 9; [Epub ahead of print

Safety of testosterone treatment in postmenopausal women.

Braunstein GD.

Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.

OBJECTIVE: To critically examine the safety of T therapy given to postmenopausal women. DESIGN: MEDLINE literature review, cross-reference of published data, and review of Food and Drug Administration transcripts. RESULT(S): Although some retrospective and observational studies provide some long-term safety data, most prospective studies have had a duration of 2 years or less. In addition, with the exception of the female-to-male transsexuals, T was administered in conjunction with estrogens or estrogens and progestins, which confound the interpretation of some of the studies. The major adverse reactions are the androgenic side effects of hirsutism and acne. There does not appear to be an increase in cardiovascular risk factors, with the exception of a lowering of high-density lipoprotein with oral T. There are little data on endometrial safety, and most of the experimental data support a neutral or beneficial effect in regards to breast cancer. There does not appear to be an increased risk of hepatotoxicity, neurobehavorial abnormalities, sleep apnea, or fetal virilization (in premenopausal women) with the physiologic treatment doses of T. CONCLUSION(S): Except for hirsutism and acne, the therapeutic administration of T in physiologic doses is safe for up to several years. However, prospectively collected long-term safety studies are needed to provide a greater degree of assurance.

 

 

Climacteric. 2007 Jun;10(3):257-63

The effects of short-term hormone replacement therapy on long-term bone mineral density.

Middleton ET, Steel SA.

Centre for Metabolic Bone Disease, Hull Royal Infirmary. Hull. UK.

Introduction Short-term hormone replacement therapy (HRT) relieves menopausal symptoms and increases bone mineral density (BMD), but bone loss reoccurs upon discontinuation. This study assesses whether short-term HRT provides long-term BMD benefits. Method This was a prospective study of women aged 50-54 years followed up for 9 years. Women were categorized into three groups according to the treatment they received: No-HRT (n = 340), Short-term HRT (2-4 years, n = 60), and Long-term HRT (9 years, n = 187). Results BMD increased significantly at the hip (2.4%, p < 0.001) and spine (8.0%, p < 0.001) over 9 years in the Long-term HRT group. Women without treatment lost BMD at the hip (-4.2%, p < 0.001) and spine (-3.5%, p < 0.001). Women in the Short-term HRT group had no significant loss of BMD at the hip (-1.6%, p = 0.08) or spine (-1.4%, p = 0.18) over 9 years. BMD in the Short-term HRT group was significantly higher at 9 years than in the No-HRT group at both spine (difference 0.023 g/cm(2), p = 0.048) and hip (difference 0.016 g/cm(2), p = 0.042). Conclusion After 9 years, women who had taken short-term HRT had no significant loss of BMD and were better off in terms of BMD than those left untreated. Short-term HRT in the early postmenopausal period provides long-term BMD benefits.

 

 

J Am Geriatr Soc. 2007 May;55(5):752-7

Secondary hyperparathyroidism due to hypovitaminosis d affects bone mineral density response to alendronate in elderly women with osteoporosis: a randomized controlled trial.

Barone A, Giusti A, Pioli G, Girasole G, Razzano M, Pizzonia M, Palummeri E, Bianchi G.

Department of Gerontology and Musculoskeletal Sciences, Galliera Hospital, Genoa, Italy.

OBJECTIVES: To determine whether secondary hyperparathyroidism (HPTH) due to hypovitaminosis D affects bone mineral density (BMD) response to alendronate (ALN) in elderly women with osteoporosis. DESIGN: Randomized, controlled trial with 1-year follow-up. SETTING: Two osteoporosis centers in northern Italy. PARTICIPANTS: Community-dwelling women aged 60 and older with a BMD T-score below -2.5 and secondary HPTH with vitamin D insufficiency. INTERVENTION: One hundred twenty subjects were randomly assigned to receive ALN 70 mg once a week alone or ALN 70 mg once a week plus calcitriol (1,25D3) 0.5 mug daily. MEASUREMENTS: BMD measured using dual-energy x-ray absorptiometry at the lumbar spine (L1-L4), femoral neck, and total hip and serum levels of intact PTH at baseline and 12 months. RESULTS: After 1 year, BMD of the lumbar spine, femoral neck, and total hip significantly increased from baseline in both groups (P<.001). Patients allocated to ALN plus 1,25D3 demonstrated a significantly higher increase in lumbar spine BMD than those receiving ALN alone (mean percentage+/-standard deviation 6.8+/-4.6 vs 3.7+/-3.2, P<.001). Serum levels of PTH did not change significantly at 1 year in the ALN group (mean percentage, -3.7+/-27.1, P=.13) but decreased significantly in the ALN plus 1,25D3 group (-32.1+/-22.1, P<.001). At 12 months, subjects with normalized PTH independent of therapy allocation had a greater increase in lumbar spine BMD than those with persistent HPTH (6.5+/-4.6% vs 3.7+/-3.4%, P<.001). Lumbar spine BMD changes showed a significant negative correlation with PTH at 1 year (correlation coefficient (rho) =-0.399, P<.001) and a positive correlation with PTH changes (i.e., baseline value - 1 year value; rho=0.295, P=.005). CONCLUSION: Persistence of secondary HPTH reduces BMD response to ALN in older women with osteoporosis.

 

 

Clin Endocrinol (Oxf). 2007 May;66(5):626-31

Effects of the route of oestrogen administration on IGF-1 and IGFBP-3 in healthy postmenopausal women: results from a randomized placebo-controlled study.

Sonnet E, Lacut K, Roudaut N, Mottier D, Kerlan V, Oger E.

Service Endocrinologie, CHU de Brest, Hopital Cavale Blanche, Brest, France. emmanuel.sonnet@chu-brest.fr

OBJECTIVE: Oestrogens can modulate the action or secretion of GH. Previous studies in postmenopausal women have shown a differential effect between transdermal 17beta-oestradiol and oral ethynyl-oestradiol on GH and IGF-1 concentrations. This secondary analysis, based on a large randomized trial, aimed to estimate the effect of the route of administration of 17beta-oestradiol in combined hormone replacement therapy with progesterone on IGF-1 and IGFBP-3 levels. DESIGN: IGF-1 and IGFBP-3 were evaluated in a randomized study of 196 healthy postmenopausal women who were randomly allocated to receive on a continuous basis either 1 mg of 17beta-oestradiol orally combined with a daily intake of 100 mg progesterone (group 1; n = 63), or 50 microg of 17beta-oestradiol transdermally combined with a daily intake of 100 mg progesterone (group 2; n = 68), or triple dummy placebo (group 3; n = 65) over a 6-month period. IGF1 and IGFBP-3 levels were available for 133 women. RESULTS: Oral oestrogen significantly decreased IGF-1 levels compared to placebo (P = 0.04) and transdermal oestrogen (P = 0.004), whereas transdermal oestrogen had no effect on IGF-1 levels compared to placebo (P = 0.56). As regards IGFBP-3, no significant difference was detected between the three groups. CONCLUSIONS: Our data indicate that the route of oestrogen administration can influence IGF-1 levels. IGF-1 concentrations decreased significantly with oral oestrogen, whereas no significant change was observed with transdermal oestrogen at 6 months. The clinical relevance of these differential effects remains to be determined, particularly with regard to the risk for cardiovascular diseases.

 

 

Osteoporos Int. 2007 May 11; [Epub ahead of print

Associations between the metabolic syndrome and bone health in older men and women: the Rancho Bernardo Study.

von Muhlen D, Safii S, Jassal SK, Svartberg J, Barrett-Connor E.

Family and Preventive Medicine, UCSD, 9500 Gilman Dr., La Jolla, CA, 92093-0631C, USA, dvonmuhlen@ucsd.edu.

We examined the associations of metabolic syndrome (MS) with BMD, osteoporosis, and osteoporotic fractures in 417 men and 671 women from the Rancho Bernardo Study. After adjusting for BMI, MS was associated with lower, not higher BMD. Incidence of osteoporotic non-vertebral fractures was higher in participants with MS. MS may be another risk factor for osteoporotic fractures. INTRODUCTION: The metabolic syndrome (MS) is a cluster of risk factors, including abdominal obesity, high glucose, triglycerides, hypertension and low HDL levels, associated with cardiovascular disease morbidity. The association between components of the MS and bone mineral density (BMD) has been researched, but results are contradictory. METHODS: We used multivariate regression models to examine the cross-sectional associations of MS defined by NCEP-ATP III criteria with BMD and osteoporosis, and the longitudinal association of MS with fractures in 420 men and 676 women from the Rancho Bernardo Study. RESULTS: Prevalence of MS at baseline was 23.5% in men and 18.2% in women. In age-adjusted analyses, men and women with MS had higher BMD at total hip when compared to those without MS (p < 0.001 and p = 0.01, respectively). Men but not women with MS also had higher BMD at femoral neck (p = 0.05). After adjusting for BMI, these associations were reversed, such that MS was associated with lower and not higher BMD. CONCLUSION: Incidence of osteoporotic non-vertebral fractures was higher in participants with MS. MS may be another risk factor for osteoporotic fractures. The association of MS with higher BMD was explained by the higher BMI in those with MS.

 

 

Osteoporos Int. 2007 May 10; [Epub ahead of print

Cardiovascular diseases and future risk of hip fracture in women.

Sennerby U, Farahmand B, Ahlbom A, Ljunghall S, Michaelsson K.

Department of Surgical Sciences, Section of Orthopaedics, University Hospital, 751 85, Uppsala, Sweden, ulf.sennerby@surgsci.uu.se.

We used a population-based case-control study in women and linkage to the Swedish in-patient register to examine if there is an increased risk of hip fracture after a cardiovascular disease. There was a substantially increased risk of hip fracture after a diagnosis of a cardiovascular disease. INTRODUCTION: Recent data have indicated that cardiovascular diseases (CVDs) might have a relationship to osteoporosis, which may explain the increased risk of mortality after hip fracture. It is uncertain, however, whether there is an increased risk of fracture after any cardiovascular disease and in subgroups of CVDs. The objective of this study was to determine whether there are associations between CVD and future hip fracture risk. Knowledge of the risk pattern would lead to better understanding of common pathologic pathways of osteoporosis and CVD. METHODS: We conducted a population-based case-control study of 1,327 incident hip fracture cases and 3,170 randomly selected population controls among women 50-81 years old in Sweden. Information on cardiovascular and other diseases before the fracture was obtained by linkage to the Swedish National Inpatient Register. Odds ratios (OR) and 95% confidence intervals (CI) where calculated by unconditional logistic regression. RESULTS: Before study entry, CVDs were diagnosed more than twice as commonly among fracture cases (25%) as among controls (12%). Also, after adjustment for variables including several chronic diseases, we found a doubled risk of hip fracture after a CVD event (OR 2.38; 95% CI 1.92-2.94). There was a gradient increase in risk of hip fracture with increasing number of hospitalizations for CVD and highest fracture risk occurred the first year after the CVD event. Hypertension, heart failure, and cerebrovascular lesions remained independent risk factors, with 2- to 3-fold increases in odds ratios, even after mutual adjustments for other CVDs. CONCLUSION: There was a substantially increased risk of hip fracture in women after a diagnosis of a CVD, a finding compatible with the concept of common pathologic pathways for osteoporotic fractures and CVD.

 

 

Am J Clin Nutr. 2007 May;85(5):1428-33

Effects of dietary calcium compared with calcium supplements on estrogen metabolism and bone mineral density.

Napoli N, Thompson J, Civitelli R,

Armamento-Villareal RC.

Division of Bone and Mineral Diseases, Washington University School of Medicine, St Louis, MO.

BACKGROUND: High calcium intake has been associated with both high bone mineral density (BMD) and high urinary estrogen metabolites. However, the role of dietary calcium and calcium supplements on estrogen metabolism and BMD remains unknown. OBJECTIVE: The objective was to investigate the importance of the source of calcium intake on estrogen metabolism and BMD. DESIGN: The average total daily calcium intake from supplements and diet, urinary estrogen metabolites, and spine and proximal femur BMD were studied in 168 healthy postmenopausal white women. RESULTS: Women who obtained calcium primarily from the diet or from both the diet and supplements had significantly (P = 0.03) lower ratios of nonestrogenic to estrogenic metabolites (2-hydroxyestrone 1/16alpha-hydroxyestrone) than did those who obtained calcium primarily from supplements. Adjusted BMD z scores were significantly greater in the subjects who obtained calcium primarily from the diet or from both the diet and supplements than in those who obtained calcium primarily from calcium supplements at the spine (P = 0.012), femoral neck (P = 0.02), total femur (P = 0.003), and intertrochanter (P = 0.005). This difference was evident especially in those who obtained calcium primarily from the diet, whose total calcium intake was lower than that in those who obtained calcium primarily from supplements. CONCLUSION: Calcium from dietary sources is associated with a shift in estrogen metabolism toward the active 16alpha-hydroxyl metabolic pathway and with greater BMD and thus may produce more favorable effects in bone health in postmenopausal women than will calcium from supplements.

 

 

Am J Clin Nutr. 2007 May;85(5):1361-6

Americans are not meeting current calcium recommendations.

Ma J, Johns RA, Stafford RS.

Program on Prevention Outcomes and Practices, Stanford Prevention Research Center, Stanford University, Palo Alto, CA.

BACKGROUND: Recent research has raised doubts about the efficacy of calcium supplementation in preventing fractures; however, adequate calcium intake remains important. OBJECTIVE: Using data from the 1999-2002 National Health and Nutrition Examination Survey, we assessed dietary and supplemental calcium consumption among US men and women according to risk of osteoporosis and stratified by sex, race/ethnicity, and socioeconomic status. DESIGN: We categorized risk of osteoporosis as high (having an osteoporosis diagnosis or treatment), moderate (aged >50 y), or low (aged 19-50 y). Main study outcomes included milligrams of dietary and supplemental calcium intake, likelihood of meeting national calcium adequate intake (AI) levels, and likelihood of taking supplemental calcium. RESULTS: Mean (95% CI) total calcium consumption was 944 (846, 1043) mg in the high-risk group, 821 (788, 854) mg in the moderate-risk group, and 846 (812, 871) mg in the low-risk group. Overall, 40% of the sample met the calcium AI amount and 48% reported taking supplemental calcium. After adjustment for daily caloric intake, the greater likelihood of meeting calcium AI levels was associated with [odds ratio (95% CI)] low [versus moderate, 1.5 (1.2, 1.7)] and high [versus moderate, 1.9 (1.3, 2.6)] osteoporosis risk, female sex [1.6 (1.3, 1.8)], non-Hispanic white ethnicity [versus nonwhite, 1.9 (1.7, 2.3)], and education beyond high school [versus less than high school, 1.5 (1.2, 1.9)]. These same factors were also associated with an increased likelihood of taking supplemental calcium, except for a consistent increase with higher osteoporosis risk. CONCLUSION: Many Americans-particularly men, ethnic minorities, and the socially disadvantaged-are not meeting the current recommendations for adequate calcium intake through diet alone or with supplements.

 

 

Climacteric. 2007 Jun;10(3):249-56

Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density.

Lundstrom E, Bygdeson M, Svane G, Azavedo E, von Schoultz B.

Departments of Obstetrics and Gynecology.

Objective To compare the effects of two different ultra-low doses of continuous combined hormone therapy and placebo on mammographic breast density in postmenopausal women. Methods A subpopulation of 255 postmenopausal women from the CHOICE trial were randomly assigned to 0.5 mg 17beta-estradiol (E2) + 0.25 mg norethisterone acetate (NETA), 0.5 mg E2 + 0.1 mg NETA, or placebo. Women using hormone replacement therapy (HRT) up to 2 months prior to the study were excluded; 154 women fulfilled the inclusion criteria. Mammograms were performed at baseline and after 6 months. Breast density was evaluated by visual classification scales and a computer-assisted digitized technique. Results No significant differences were detected between the active treatment groups and the placebo group in the digitized quantification. The mean baseline values for density around 20% were unchanged after 6 months. Also, visual classifications showed no increase in breast density in any study group. Conclusion In contrast to currently available bleed-free regimens, the new ultra-low-dose combination of 0.5 mg E2 and 0.1 mg NETA seems to have very little or even a neutral effect on the breast. Both digitized quantification and visual assessment of breast density were unchanged after 6 months. Larger prospective studies should be performed to confirm this new finding.

 

 

Climacteric. 2007 Jun;10(3):238-43

Number of women needed in a prospective trial to prove potential cardiovascular benefit of hormone replacement therapy.

Depypere HT, Tummers P, De Bacquer D, De Backer G, Do M, Dhont M.

Department of Gynecology.

Introduction Hormonal replacement therapy (HRT) may be beneficial for the cardiovascular system if hormones are given shortly after the onset of menopause. So far, no randomized trial has provided conclusive results. Materials and methods Based on Belgian population data, we calculated the number of women that should be included in a prospective double-blinded study to prove a potential cardiovascular benefit of HRT. Sample size calculations were based on the extrapolation of empirical observations made in three large databases from epidemiological studies carried out in Belgium during the past 20 years. Results The 10-year mortality varies with the age at which women are included in the observation. In the normal Belgian female population, the cardiovascular mortality risk is 0.85% and 1.58% for women aged 50-54 and 55-59 years, respectively. To prove that HRT induces a decrease of 10-year mortality of 30% in a normal population of 50-54-year-old women, 34 630 subjects would have to be included; for reductions of 20% and 10%, the numbers would be, respectively, 82 468 and 348 056. To prove a significant decrease in 10-year mortality starting with a normal population with an average age of 55-59 years, the numbers needed for hypothetical reductions of 30%, 20% and 10% would be, respectively, 18 514, 44 072 and 185 936. Conclusion If cardiovascular mortality is the study end-point, it is obvious that such a study will be a gigantic task. Taking cardiovascular morbidity as the end-point, such a study would be feasible.

 

 

Climacteric. 2007 Jun;10(3):197-214

Prevalence of hot flushes and night sweats around the world: a systematic review.

Freeman EW, Sherif K.

Department of Obstetrics and Gynecology, University of Pennsylvania.

Objective Many studies have evaluated the relationships between ethnicity and culture, prevalence of menopausal symptoms, and attitudes toward them, but few have assessed menopausal symptoms across cultures world-wide. This paper aims to systematically review the prevalence of hot flushes and night sweats, two prevalent symptoms of menopause, across the menopausal stages in different cultures and considers potential explanations for differences in prevalence rates. Design Sixty-six papers formed the basis for this review. Studies were organized by geographic region, and results are presented for North America, Europe, East Asia, Southeast Asia, Australia, Latin America, South Asia, Middle East, and Africa. Studies were included if they provided quantitative information on the occurrence of hot flushes. This report focuses on hot flushes and night sweats, the most common menopausal symptoms reported in epidemiologic studies. Results Studies reviewed indicate that vasomotor symptoms are highly prevalent in most societies. The prevalence of these symptoms varies widely and may be influenced by a range of factors, including climate, diet, lifestyle, women's roles, and attitudes regarding the end of reproductive life and aging. Patterns in hot flush prevalence were apparent for menopausal stages and, to a lesser degree, for regional variation. Conclusions Caregivers should recognize that variations exist and ask patients specific questions about symptoms and their impact on usual functioning.

 

 

Menopause. 2007 May 4; [Epub ahead of print

Sleep disturbance in menopause.

Freedman RR, Roehrs TA.

From the 1Departments of Psychiatry and Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI; and 2Henry Ford Hospital Sleep Disorders Center, Department of Psychiatry, Wayne State University School of Medicine, Detroit, MI.

OBJECTIVE:: To determine the sources of sleep complaints in peri- and postmenopausal women reporting disturbed sleep. DESIGN:: A total of 102 women, ages 44 to 56 years, who reported disturbed sleep were recruited through newspaper advertisements. They were assessed with the Pittsburgh Sleep Quality Index and the Hamilton Anxiety and Depression Rating Scales. Complete polysomnography was performed in a controlled laboratory setting. Results were analyzed by multiple regression. RESULTS:: Fifty-three percent of the women had apnea, restless legs, or both. The best predictors of objective sleep quality (laboratory sleep efficiency) were apneas, periodic limb movements, and arousals (R = 0.44, P < 0.0001). The best predictors of subjective sleep quality (Pittsburgh Sleep Quality Index global score) were the Hamilton anxiety score and the number of hot flashes in the first half of the night (R = 0.19, P < 0.001). CONCLUSIONS:: Primary sleep disorders (apnea and restless legs syndrome) are common in this population. Amelioration of hot flashes may reduce some complaints of poor sleep but will not necessarily alleviate underlying primary sleep disorders. Because these can result in significant morbidity and mortality, they require careful attention in peri- and postmenopausal women.

Semana del 1 al 7 de Mayo 2007

 

Dr. Juan Enrique Blümel

 

 

Breast Cancer Res. 2007 May 3;9(3):R28 [Epub ahead of print]

Recent trends in breast cancer incidence rates by age and tumor characteristics among U.S. women.

Jemal A, Ward E, Thun MJ.

ABSTRACT: BACKGROUND: A recent abstract presented in a breast cancer symposium attributed the sharp decrease in female breast cancer incidence rates from 2002 to 2003 in the Surveillance, Epidemiology, and End Results (SEER) cancer registries of the United States to the reduced use of hormone replacement therapy since July 2002. However, this hypothesis does not explain the decrease that began in 1999 in the age-standardized incidence rate of invasive breast cancer in the nine oldest SEER cancer registry areas, although the trend through 2003 was not statistically significant. In this paper, we examine temporal trends in invasive and in situ female breast cancer by age, stage, tumor size, and estrogen receptor/progestin receptor (ER/PR) status in the nine oldest SEER cancer registry areas and consider the implication of these trends in relation to risk factors and screening. METHODS: We performed a joinpoint regression analysis to fit a series of joined straight lines to the trends in age-adjusted rates and described the resultant trends (slope) by annual percentage change (two-sided, P <0.05). RESULTS: A plot of the age-specific rates of invasive breast cancer shows a decrease in all 5-year age groups from 45 years and above between 1999 and 2003 and sharp decreases largely confined to ER+ tumors in age groups from 50 to 69 years between 2002 and 2003. In joinpoint analyses by tumor size and stage, incidence rates decreased for small tumors (less than or equal to 2 cm) by 4.1% (95% confidence interval [CI], 0.2% to 7.8%) per year from 2000 through 2003 and for localized disease by 3.1% (95% CI, 1.2% to 5.0%) per year from 1999 through 2003. No decrease in incidence was observed for larger tumors or advanced-stage disease during the corresponding periods. Rates for in situ disease were stable from 2000 through 2003 after increasing rapidly since 1981. CONCLUSION: Two distinct patterns are observed in breast cancer trends. The downturn in incidence rates in all age groups above 45 years suggests a period effect that is consistent with saturation in screening mammography. The sharp decrease in incidence from 2002 to 2003 that occurred in women 50 to 69 years old who predominantly, but not exclusively, had ER+ tumors may reflect the early benefit of the reduced use of hormone replacement therapy.

 

 

Climacteric. 2007 Apr;10(2):164-70

The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III): prevalence of the metabolic syndrome in postmenopausal Latin American women.

Royer M, Castelo-Branco C, Blumel JE, Chedraui PA, Danckers L, Bencosme A, Navarro D, Vallejo S, Espinoza MT, Gomez G, Izaguirre H, Ayala F, Martino M, Ojeda E, Onatra W, Saavedra J, Tserotas K, Pozzo E, Manriquez V, Prada M, Grandia E, Zuniga C, Lange D, Sayegh F, America FT.

Background Metabolic syndrome (METS) is a strong predictor of cardiovascular risk. Since the prevalence of METS increases after menopause, gynecological routine consultation offers an excellent screening opportunity. Objectives To assess the prevalence of METS in Latin American postmenopausal women and factors modifying its risk; as well as to assess the role of simple routine care measurements in the diagnosis of the METS. Methods A total of 3965 postmenopausal women, aged 45-64 years, seeking health care at 12 gynecological centers in major Latin American cities were included in this cross-sectional study. The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) guidelines were applied to assess METS. This was present if three or more of the following conditions were present: waist circumference >/= 88 cm; blood pressure >/= 130/85 mmHg; fasting plasma triglycerides >/= 150 mg/dl; high density lipoprotein (HDL) cholesterol < 50 mg/dl; glucose >/= 110 mg/dl or subjects were receiving treatment for their condition. Results The prevalences of having at least two, three, four or five components were 62.5, 35.1, 13.5 and 3.2%, respectively. The prevalence increased from 28.1% in those aged 40-44 years to 42.9% in those aged 60-64 years. The risk of METS detection (multivariate analysis) increased with age (odds ratio (OR) 1.22, 95% confidence interval (CI) 1.03-1.43), time elapsed since menopause (OR 1.18, 95% CI 1.00-1.38), smoking cigarettes (OR 1.40, 95% CI 1.19-1.65), obesity (OR 13.01, 95% CI 10.93-15.49) and hypertension (OR 9.30, 95% CI 7.91-10.94). In contrast, hormone therapy reduces this risk (OR 0.59, 95% CI 0.51-0.70). Conclusion There is a high prevalence of the metabolic syndrome in postmenopausal Latin American women seeking gynecologic health care. Age, years since menopause, obesity and hypertension are strong predictors of this condition.

 

 

Menopause. 2007 May-Jun;14(3 Suppl):592-7.

Options for hormone therapy in women who have had a hysterectomy.

Haney AF, Wild RA.

Department of Obstetrics and Gynecology, The University of Chicago, Chicago, IL; and 2Departments of Obstetrics and Gynecology, and Biostatistics and Epidemiology, Oklahoma University Health Sciences Center, Oklahoma.

OBJECTIVE:: To review postmenopausal hormone therapy for women who have undergone hysterectomy with or without bilateral oophorectomy and to make clinical recommendations regarding changes in regimens compared with those for women with their uterus in place. DESIGN:: We conducted a literature review, including a review of current guidelines. RESULTS:: When the uterus is absent, estrogen treatment is all that is needed when hot flashes and/or genital atrophic symptoms are associated with surgical or natural menopause. Reasons to add a progestogen to an estrogen-only therapy regimen after hysterectomy include the need to reduce the risk for unopposed estrogen-dependent conditions, chief among which are endometriosis or endometrial neoplasia. Multiple lines of evidence suggest that regimens containing both estrogen and progestogen versus estrogen alone are associated with a greater relative risk of breast cancer without additional improvement in relief of hot flashes or vaginal symptoms. When a bilateral oophorectomy is performed before natural menopause, the onset of menopausal symptoms, primarily vasomotor symptoms, genital tract atrophy, and/or a decline in sexual function, is rapid, and the symptoms are more severe. Thus, the need for a decision on the use of hormone therapy is accelerated. CONCLUSIONS:: The decision to use or not use menopausal hormone therapy in women without a uterus should involve an individualized risk/benefit analysis just as it should when the uterus is present. After hysterectomy, for most patients, current literature results favor not including a progestogen. Data suggest an attenuation of the potential cardiovascular benefit of estrogen therapy in this situation, yet no better protection against bone fractures and an increase in the risk for breast cancer when both estrogen and progestogen are used.

 

 

Menopause. 2007 May-Jun;14(3 Suppl):586-91.

Surgical menopause: effects on psychological well-being and sexuality.

Shifren JL, Avis NE.

From 1Vincent Ob/Gyn Service, Massachusetts General Hospital, Harvard Medical School, Boston, MA; and 2Wake Forest University Health Sciences, Winston-Salem, NC.

OBJECTIVE:: Women anticipating surgical menopause often have significant concerns regarding the effects of surgery on psychological well-being and sexuality. RESULTS:: The impact of hysterectomy, often with concurrent oophorectomy, on well-being and sexuality will vary depending on many factors. These include a woman's preoperative mental health and sexual function, the indications for surgery, and the specific procedure being performed. Whether or not estrogen therapy is an option also will affect a woman's postoperative symptoms and experience of surgical menopause. CONCLUSIONS:: The majority of research on the effects of surgical menopause shows improved psychological well-being and sexual function after hysterectomy for benign disease. Women with depression or sexual problems preoperatively are at increased risk for experiencing a worsening of mood and libido postoperatively.

 

 

Menopause. 2007 May/June;14(7 Suppl. 1):580-585.

Elective oophorectomy for benign gynecological disorders.

Shoupe D, Parker WH, Broder MS, Liu Z, Berek JS.

Keck School of Medicine of the University of Southern California, Los Angeles, Ca.

OBJECTIVE:: To review the risks and benefits of elective oophorectomy and to make a clinical recommendation for an appropriate age when benefits of this procedure outweigh the risks. DESIGN:: The risks and benefits of oophorectomy as detailed in published articles are reviewed with regard to quality-of-life issues and mortality outcomes in oophorectomized versus nonoophorectomized women from five diseases linked to ovarian hormones (coronary heart disease, ovarian cancer, breast cancer, stroke, and hip fracture). RESULTS:: Numerous reports link oophorectomy to higher rates of cardiovascular disease, osteoporosis, hip fractures, dementia, short-term memory impairment, decline in sexual function, decreased positive psychological well-being, adverse skin and body composition changes, and adverse ocular changes, as well as more severe hot flushes and urogenital atrophy. The potential benefits associated with oophorectomy include prevention of ovarian cancer, a decline in breast cancer risk, and a reduced risk of pelvic pain and subsequent ovarian surgery. In our study of long-term mortality after oophorectomy using Markov modeling, preservation of ovaries until women are at least aged 65 years was associated with higher survival rates. For women between ages 50 and 54 with hysterectomy and ovarian preservation, the probability of surviving to age 80 was 62% versus 54% if oophorectomy was performed. This 8% difference in survival is primarily due to fewer women dying from cardiovascular heart disease and/or hip fracture. This survival advantage far outweighs the 0.47% increased mortality rate from ovarian cancer prevented by oophorectomy. If surgery occurred between ages 55 and 59, the survival advantage was 4%. After age 64 there were no significant differences in survival rates. Prior literature supports our conclusion of a benefit over risk for ovarian conservation. CONCLUSIONS:: Elective oophorectomy is associated with short-and long-term health consequences that merit serious consideration. For women with an average risk of ovarian cancer, ovarian conservation until at least age 65 seems to benefit long-term survival.

 

 

Menopause. 2007 May/June;14(7 Suppl. 1):572-579.

Surgical versus natural menopause: cognitive issues.

Henderson VW, Sherwin BB.

Department of Health Research and Policy (Epidemiology), Stanford University, Stanford, CA, Canada.

OBJECTIVE:: Women who undergo both natural and surgical menopause experience the loss of cyclic ovarian production of estrogen, but hormonal and demographic differences distinguish these two groups of women. Our objective was to review published evidence on whether the premature cessation of endogenous estrogen production in women who underwent a surgical menopause has deleterious consequences for cognitive aging and to determine whether consequences differ for women if they undergo natural menopause. Studies of estrogen-containing hormone therapy are relevant to this issue. DESIGN:: We reviewed evidence-based research, including the systematic identification of randomized clinical trials of hormone therapy with cognitive outcomes that included an objective measure of episodic memory. RESULTS:: As inferred from very small, short-term, randomized, controlled trials of high-dose estrogen treatment, surgical menopause may be accompanied by cognitive impairment that primarily affects verbal episodic memory. Observational evidence suggests that the natural menopausal transition is not accompanied by substantial changes in cognitive abilities. For initiation of hormone therapy during perimenopause or early postmenopause when the ovaries are intact, limited clinical trial data provide no consistent evidence of short-term benefit or harm. There is stronger clinical trial evidence that initiation of hormone therapy in late postmenopause does not benefit episodic memory or other cognitive skills. CONCLUSIONS:: Further research is needed on the long-term cognitive consequences of surgical menopause and long-term cognitive consequences of hormone therapy initiated near the time of surgical or natural menopause. A potential short-term cognitive benefit might be weighed when a premenopausal woman considers initiation of estrogen therapy at the time of, or soon after, hysterectomy and oophorectomy for benign conditions, although data are still quite limited and estrogen is not approved for this indication. Older postmenopausal women should not initiate hormone therapy to improve or maintain cognitive skills.

 

 

Menopause. 2007 May-Jun;14(3 Suppl):567-71.

Effect of early menopause on bone mineral density and fractures.

Gallagher JC.

From the Creighton University Medical Center, Omaha, NE.

OBJECTIVE:: To review the data on the effect of early menopause on bone. Do women undergoing early menopause develop lower bone mineral density at an earlier age and do they have a higher incidence of osteoporotic fractures? Is there a difference on bone between women who undergo early natural menopause compared to women who have early menopause after oophorectomy? RESULTS:: The earlier in life that menopause occurs, the lower the bone density will be later in life. Low bone density is associated with a higher fracture rate, and several studies show a relationship between early menopause, oophorectomy, and an increase in osteoporotic fractures. CONCLUSIONS:: Early menopause is a risk factor for osteoporosis. Women with an early menopause should have bone density testing performed within 10 years of menopause so that osteopenia or osteoporosis will be diagnosed early and appropriate antiresorptive therapy initiated.

 

 

Menopause. 2007 May-Jun;14(3 Suppl):562-6.

Surgical menopause and cardiovascular risks.

Lobo RA.

Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.

OBJECTIVE & DESIGN:: To review the relevant literature on the effect of surgical menopause on cardiovascular disease (CVD). RESULTS & CONCLUSIONS:: Early menopause (before age 50) is associated with an increased risk of CVD. Bilateral oophorectomy around the time of menopause may impart either a small influence or no effect on increasing the risk of CVD; however, bilateral oophorectomy before menopause significantly increases the risk. Some data suggest a protective effect of estrogen therapy in this setting exist. The CVD risk is principally that of coronary heart disease and not cerebrovascular disease. Mortality rates may be increased in women with early menopause, either spontaneous or surgically induced. Hysterectomy per se, without bilateral oophorectomy, does not seem to increase CVD risk.

 

 

N Engl J Med. 2007 May 3;356(18):1809-22.

Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis.

Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, et al.

University of California, San Francisco, San Francisco, CA 94107, USA. dblack@psg.ucsf.edu

BACKGROUND: We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period. METHODS: In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. RESULTS: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001). CONCLUSIONS: A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures.

 

 

Nutr Cancer. 2006;56(2):128-35.

Associations between soy, diet, reproductive factors, and mammographic density in singapore chinese women.

Ursin G, Sun CL, Koh WP, Khoo KS, Gao F, Wu AH, Yu MC.

Abstract: Although the evidence is not completely consistent, soy intake has been inversely associated with breast cancer risk, and the strongest results have been observed in certain Asian populations. To address this issue and to examine the association between mammographic density and reproductive factors in this population, we conducted a crosssectional analysis of mammograms and validated food-frequency questionnaires from 380 Chinese women living in Singapore. Percent mammographic density, a biomarker for breast cancer risk, was assessed using a validated computer-assisted method. We used generalized linear models to estimate mean mammographic density by quartiles of soy intake and intake of other dietary factors while adjusting for potential confounders. Percent mammographic density was inversely associated with age, body mass index, parity, breastfeeding, and soy intake. The difference in mammographic density between the highest and lowest quartiles of soy intake was 4-5%; this difference was statistically significant for soy protein and soy isoflavone intake and is similar in magnitude to what has been reported in Western populations when women undergo menopause or commence hormone therapy. We found no evidence that high fiber, fruit, or vegetable intake has protective effects on mammographic density. Our results suggest that the effect of soy intake on percent mammographic density is moderate but possibly of clinical relevance.

 

 

Nutr Cancer. 2006;56(2):253-9.

A traditional mediterranean diet decreases endogenous estrogens in healthy postmenopausal women.

Carruba G, Granata OM, Pala V, Campisi I, Agostara B, Cusimano R, Ravazzolo B, Traina A.

Abstract: Breast cancer incidence and mortality rates are markedly lower in the south than in the north of Europe. This has been ascribed to differences in lifestyle and, notably, dietary habits across European countries. However, little information exists on the influence of different dietary regimens on estrogens and, hence, on breast cancer risk. Here we report results of our MeDiet Project, a randomized, dietary intervention study aimed to assess the effect of a Mediterranean diet on the profiles of endogenous estrogens in healthy postmenopausal women. Out of the 230 women who initially volunteered to participate in the study, 115 were found to be eligible and were enrolled. Women were then randomly assigned into an intervention (n = 58) and a control (n = 57) group. Women in the intervention group adhered to a traditional, restricted Mediterranean diet for 6 mo, whereas women in the control group continued to follow their regular diet. Women in the intervention group changed their dietary regimen substantially, and this eventually led to a shift from a prevalent intake of animal fat and proteins to a prevalent intake of vegetable fat and proteins. Regarding urinary estrogens, no significant difference was observed between the intervention and control groups at baseline. After 6 mo, however, control women did not show any major change but women in the intervention group exhibited a significant decrease (over 40%) of total estrogen levels (P < 0.02). The largest part of this modification was based on a marked decrease of specific estrogen metabolites, including hydroxyand keto-derivatives of estradiol or estrone. To our knowledge, this is the first report to show that a traditional Mediterranean diet significantly reduces endogenous estrogen. This may eventually lead to identify selected dietary components that more effectively decrease estrogens levels and, hence, provide a basis to develop dietary preventive measures for breast cancer.

 

 

Nutr Cancer. 2006;56(2):128-35.

Associations between soy, diet, reproductive factors, and mammographic density in singapore chinese women.

Ursin G, Sun CL, Koh WP, Khoo KS, Gao F, Wu AH, Yu MC.

Abstract: Although the evidence is not completely consistent, soy intake has been inversely associated with breast cancer risk, and the strongest results have been observed in certain Asian populations. To address this issue and to examine the association between mammographic density and reproductive factors in this population, we conducted a crosssectional analysis of mammograms and validated food-frequency questionnaires from 380 Chinese women living in Singapore. Percent mammographic density, a biomarker for breast cancer risk, was assessed using a validated computer-assisted method. We used generalized linear models to estimate mean mammographic density by quartiles of soy intake and intake of other dietary factors while adjusting for potential confounders. Percent mammographic density was inversely associated with age, body mass index, parity, breastfeeding, and soy intake. The difference in mammographic density between the highest and lowest quartiles of soy intake was 4-5%; this difference was statistically significant for soy protein and soy isoflavone intake and is similar in magnitude to what has been reported in Western populations when women undergo menopause or commence hormone therapy. We found no evidence that high fiber, fruit, or vegetable intake has protective effects on mammographic density. Our results suggest that the effect of soy intake on percent mammographic density is moderate but possibly of clinical relevance.

 

 

Clin Ther. 2007 Feb;29(2):230-41.

Therapeutic options for the management of hot flashes in breast cancer survivors: An evidence-based review.

Bordeleau L, Pritchard K, Goodwin P, Loprinzi C.

Department of Medical Oncology, University of Toronto, Toronto, Canada.

BACKGROUND:: Women with breast cancer may experiencetreatment-induced menopausal symptoms or natural menopause. Menopausal symptoms, particularly hot flashes, are reported at a high frequency in this group and tend to be more severe, distressing, and of greater duration than in controls. Because of the contribution of sex hormones to breast cancer, the use of hormonal agents for the control of hot flashes is problematic in these women. Safer nonhormonal alternatives are recommended for this patient group. OBJECTIVES:: This was a systematic review of thetherapeutic options for the treatment of hot flashes in breast cancer survivors. METHODS:: MEDLINE was searched from 1990 to July 2006 using the disease-specific term breast neoplasms and the subheadings menopause and hot flashes. EMBASE was searched from 1990 to March 2006 using the disease-specific subject headings breast tumor/ breast cancer and menopause and the key word hot flashes. The reference lists of the identified articles and relevant review articles were examined for additional publications. Pertinent articles and abstracts of large randomized controlled trials focusing on the treatrment of hot flashes in breast cancer survivors were selected for review. Pilot studies were excluded. RESULTS:: A number of nonpharmacologic approaches are available for the treatment of hot flashes in breast cancer survivors, although they appear to be of limited effectiveness. Complementary alternative medicine therapies and vitamin E have been found to have modest effectiveness at best, and data on their long-term safety are not available. Centrally active agents such as the antidepressants venlafaxine and paroxetine and the antiseizure agent gabapentin have shown clinical effectiveness and appear to be reasonably well tolerated in this population. CONCLUSIONS:: Centrally active agents (eg, venlafaxme, paroxetine, gabapentin) are regarded as the most promising nonhormonal treatments for hot flashes in breast cancer survivors. Nonpharmacologic and complementarylalternative medicine therapies have limited effectiveness.

 

 

J Natl Cancer Inst. 2007 May 2;99(9):672-9

Randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido; North Central Cancer Treatment Group protocol N02C3.

Barton DL, Wender DB, Sloan JA, Dalton RJ, Balcueva EP, Atherton PJ, Bernath AM Jr, DeKrey WL, Larson T, et al

Department of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.

BACKGROUND: Decreased libido is one of several changes in sexual function that are often experienced by female cancer patients. Transdermal testosterone therapy has been associated with increased libido among estrogen-replete women who report low libido. METHODS: In a phase III randomized, placebo-controlled crossover clinical trial, we evaluated whether transdermal testosterone would increase sexual desire in female cancer survivors. Postmenopausal women with a history of cancer and no current evidence of disease were eligible if they reported a decrease in sexual desire and had a sexual partner. Eligible women were randomly assigned to receive 2% testosterone in Vanicream for a testosterone dose of 10 mg daily or placebo Vanicream for 4 weeks and were then crossed over to the opposite treatment for an additional 4 weeks. The primary endpoint was sexual desire or libido, as measured using the desire subscales of the Changes in Sexual Functioning Questionnaire, as assessed at baseline and at the end of 4 and 8 weeks of treatment. Serum levels of bioavailable testosterone were measured at the same times. All statistical tests were two-sided. RESULTS: We enrolled 150 women. Women who were on active testosterone cream had higher serum levels of bioavailable testosterone than women on placebo (mean change from baseline, testosterone versus placebo, week 4, 11.57% versus 0%, difference = 11.57%, 95% confidence interval [CI] = 8.49% to 14.65%; week 8, 10.21% versus 0.28%, difference = 9.92%, 95% CI = 5.42% to 14.42%; P<.001 for all). However, the average intrapatient libido change from baseline to weeks 4 and 8 was similar on both arms. CONCLUSION: Increased testosterone level did not translate into improved libido, possibly because women on this study were estrogen depleted.

 

 

Diabetes Care. 2007 Apr 27; [Epub ahead of print

Insulin Sensitivity and Insulin Secretion Determined by the Homeostasis Model Assessment (HOMA) and Risk of Diabetes Mellitus in a Multi-Ethnic Cohort of Women: The Women's Health Initiative Observational Study.

Song Y, Manson JE, Tinker L, Howard BV, Kuller LH, Nathan L, Rifai N, Liu S.

Division of Preventive Medicine, Medicine, Brigham and Women's Hospital, Boston, Massachusetts.

The homeostasis model assessment (HOMA) based on plasma levels of fasting glucose and insulin has been widely validated and applied for quantifying insulin resistance and beta-cell function. However, prospective data regarding its relation to diabetes risk in ethnically diverse populations are limited. DESIGN AND METHODS Among 82,069 women aged 50 to 79 years free of cardiovascular disease or diabetes participating in the Women's Health Initiative Observational Study (WHI-OS), we conducted a nested case-control study to prospectively examine the relations of HOMA-insulin resistance (HOMA-IR) and beta-cell function (HOMA-%B) with diabetes risk. During a median follow-up period of 5.9 years, 1,584 diabetes patients were matched with 2,198 controls by age, ethnicity, clinical center, time of blood draw, and follow-up time. RESULTS Baseline levels of fasting glucose, insulin, and HOMA-IR were each significantly higher among cases than controls while HOMA-%B was lower (all P values<0.0001). After adjustment for matching factors and diabetes risk factors, all four markers were significantly associated with diabetes risk; the estimated relative risks (RRs) per standard deviation increment were 3.54 (95% CI, 3.02-4.13) for fasting glucose, 2.25 (1.99-2.54) for fasting insulin, 3.40 (2.95-3.92) for HOMA-IR, and 0.57(0.51-0.63) for HOMA-%B. While no statistically significant multiplicative interactions were observed between these markers and ethnicity, the associations of both HOMA-IR and HOMA-%B with diabetes risk remained significant and robust in each ethnic group including Whites, Blacks, Hispanics, and Asians/Pacific Islanders. When evaluated jointly, the relations of HOMA-IR and HOMA-%B with diabetes risk appeared to be independent and additive. HOMA-IR was more strongly associated with an increased risk than were other markers after we excluded those with a fasting glucose >/= 126 mg/dl at baseline. CONCLUSIONS High HOMA-IR and low HOMA%B were independently and consistently associated with an increased diabetes risk in a multi-ethnic cohort of US postmenopausal women. These data suggest the values of HOMA indices for diabetes risk in epidemiologic studies.