CONTEXT: Alendronate sodium reduces fracture risk in postmenopausal women who have vertebral fractures, but its effects on fracture risk have not been studied for women without vertebral fractures. OBJECTIVE: To test the hypothesis that 4 years of alendronate would decrease the risk of clinical and vertebral fractures in women who have low bone mineral density (BMD) but no vertebral fractures. DESIGN: Randomized, blinded, placebo-controlled trial. SETTING: Eleven community-based clinical research centers. SUBJECTS: Women aged 54 to 81 years with a femoral neck BMD of 0.68 g/cm2 or less (Hologic Inc, Waltham, Mass) but no vertebral fracture; 4432 were randomized to alendronate or placebo and 4272 (96%) completed outcome measurements at the final visit (an average of 4.2 years later). INTERVENTION: All participants reporting calcium intakes of 1000 mg/d or less received a supplement containing 500 mg of calcium and 250 IU of cholecalciferol. Subjects were randomly assigned to either placebo or 5 mg/d of alendronate sodium for 2 years followed by 10 mg/d for the remainder of the trial. MAIN OUTCOME MEASURES: Clinical fractures confirmed by x-ray reports, new vertebral deformities detected by morphometric measurements on radiographs, and BMD measured by dual x-ray absorptiometry. RESULTS: Alendronate increased BMD at all sites studied (P<.001) and reduced clinical fractures from 312 in the placebo group to 272 in the intervention group, but not significantly so (14% reduction; relative hazard [RH], 0.86; 95% confidence interval [CI], 0.73-1.01). Alendronate reduced clinical fractures by 36% in women with baseline osteoporosis at the femoral neck (>2.5 SDs below the normal young adult mean; RH, 0.64; 95% CI, 0.50-0.82; treatment-control difference, 6.5%; number needed to treat [NNT], 15), but there was no significant reduction among those with higher BMD (RH, 1.08; 95% CI, 0.87-1.35). Alendronate decreased the risk of radiographic vertebral fractures by 44% overall (relative risk, 0.56; 95% CI, 0.39-0.80; treatment-control difference, 1.7%; NNT, 60). Alendronate did not increase the risk of gastrointestinal or other adverse effects. CONCLUSIONS: In women with low BMD but without vertebral fractures, 4 years of alendronate safely increased BMD and decreased the risk of first vertebral deformity. Alendronate significantly reduced the risk of clinical fractures among women with osteoporosis but not among women with higher BMD.

Absorptiometry, Photon↗

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Hypercholesterolemia predicts early death from coronary heart disease in elderly men but not women. The Rancho Bernardo Study.

In a 3-year follow-up study of 761 elderly men and 983 elderly women, total plasma cholesterol levels predicted fatal coronary heart disease (CHD) in men but not women. Low-density lipoprotein level was no better a predictor of fatal CHD than total cholesterol in either sex. Women had higher levels of high-density lipoprotein than men, which explains most of their usual higher total cholesterol levels. These data suggest that cholesterol screening of elderly women would have little value without a lipoprotein evaluation.

Aged↗

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Cholesterol and heart disease in older persons and women. Review of an NHLBI workshop.

The value of serum total cholesterol measurement in predicting coronary heart disease (CHD) is well established in middle-aged men, but has been questioned in middle-aged women and older people of both sexes. To address this, the most recent follow-up data from 25 populations in 22 US and international cohort studies were presented and analyzed at a recent National Heart, Lung, and Blood Institute (NHLBI) workshop. Crude relative and absolute excess risks of fatal CHD were determined for individual studies and pooled across studies to determine pooled risk estimates. Serum total cholesterol and low-density-lipoprotein (LDL) cholesterol levels predicted fatal CHD in middle-aged (< 65 years) and older (> or = 65 years) men and women, though the strength and consistency of these relationships in older women were diminished. High-density-lipoprotein (HDL) cholesterol levels inversely predicted CHD in middle-aged men and women and in older women, but not in older men. Data for minority groups and for overseas populations were similar to those for white people in the United States. Relative risk estimates were generally lower for older than for middle-aged subjects, but absolute excess risk was greater. Older people and middle-aged women with elevated cholesterol levels are clearly at increased risk of coronary disease; whether this risk can be modified by dietary or drug therapy, and at what level intervention is appropriate, must not be determined.

Age Factors↗

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Postmenopausal hormone use following a 3-year randomized clinical trial.

Postmenopausal women often discontinue estrogen therapy within the first year. No studies have examined reasons why women continue or discontinue hormone replacement therapy (HRT) after several years of use, when hormone side effects have subsided. We wanted to identify determinants of estrogen use after participation in a 3-year randomized placebo-controlled trial. The Postmenopausal Estrogen/Progestin Intervention (PEPI) study compared the effects of estrogen alone or in combination with one of three progestogens with placebo. Post-PEPI use of hormone therapy was ascertained 1-4 years after the trial in 775 (90%) of the originally enrolled women. Potential correlates of treatment decisions were identified from sociodemographic characteristics, medical histories, and clinical measures ascertained at baseline and during and after the trial. Among women who had been assigned to placebo during PEPI, post-PEPI hormone use was significantly less common in women who were adherent to placebo during PEPI, older, or of non-Caucasian ethnicity. Hormone use was positively associated with hysterectomy. Among women assigned to an active regimen during PEPI, post-PEPI hormone use was significantly more common in women who used hormones before PEPI and in women who were adherent to hormones during PEPI. Older age, less education, and being non-Caucasian predicted less hormone use. Post-PEPI hormone use was highest in San Diego and lowest in Iowa City. Women on placebo who lost more bone mineral density (BMD) were more likely to begin hormones than women with less bone loss. Lipids, blood pressure, and other cardiovascular risk factors had relatively little influence on hormone use. The main predictors of post-PEPI hormone use were those associated with use in the general population (education, ethnicity, geographical region, hysterectomy, and prior use/adherence).

Age Factors↗

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Cross-sectional association between markers of inflammation and serum sex steroid levels in the postmenopausal estrogen/progestin interventions trial.

BACKGROUND: Standard risk factors do not adequately capture cardiovascular risk in postmenopausal women. We sought to determine the associations between levels of sex steroids and levels of inflammatory markers in postmenopausal women. METHODS: We analyzed baseline data from a subset of postmenopausal women aged 45-64 years who had stored samples during a randomized controlled trial. We measured levels of C-reactive protein (CRP), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), soluble intercellular adhesion molecule (sICAM), and circulating sex steroids. Multiple linear regression models were created with each of the following hormone levels as the primary exposure variable: estrone, total estradiol, bioavailable estradiol, total testosterone, bioavailable testosterone, progesterone, and sex hormone-binding globulin (SHBG). Sociodemographic and lifestyle covariates were derived from standardized self-report questionnaires and direct measurement (weight, height). RESULTS: Mean age of the 623 women was 56 years. After adjustment for age, body mass index (BMI), physical activity, alcohol consumption, and smoking, the bioavailable testosterone level (p = 0.03) was positively and the SHBG level (p < 0.001) was negatively associated with the logCRP level. The increment in CRP level between the highest and lowest quartile of bioavailable testosterone was 1.28 microg/mL. The increment in CRP level between the lowest and highest quartile of SHBG was 2.62 microg/mL. Compared with SHBG or bioavailable testosterone as predictors of logCRP in separate regression models, when both SHBG and bioavailable testosterone were included in the same multivariate linear regression model, only SHBG remained a statistically significant predictor of logCRP. Progesterone level was positively associated with the logMMP-9 level (p < 0.001); no other sex steroid level was associated with the logMMP-9 level. In multiply adjusted models, no association was found between levels of any sex steroid and IL-6 or sICAM level.

Alcohol Drinking↗

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Is insulin-dependent diabetes mellitus caused by coxsackievirus B infection? A review of the epidemiologic evidence.

The evidence that coxsackievirus B plays a causal role in the etiology of insulin-dependent diabetes mellitus (IDDM) is reviewed. This hypothesis is biologically plausible; one variant of another picornavirus, encephalomyocarditis virus, causes diabetes in genetically susceptible mice, but prior infection with another, serologically indistinguishable variant prevents this. The seasonal distributions of infection due to coxsackievirus B and of IDDM are similar. Case reports document coxsackievirus B infection coincident with the onset of IDDM. More than one-third of patients with recent-onset IDDM have antibody to coxsackievirus B but have not necessarily had recent infection. Case-control studies show no consistent association, with odds ratios ranging from 0.7 to 20. In two prospective studies, IDDM did not follow coxsackievirus B epidemics, but the sample sizes were small. Although epidemiologic data are too inconsistent to allow one to conclude that coxsackievirus B is a frequent cause of IDDM, methodologic difficulties--illustrated in the animal model--suggest that it would be premature to discard this hypothesis.

Adolescent↗

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The prophylaxis of gonorrhea.

The current level of the gonorrhea epidemic supports the need for additional measures for gonorrhea control. In the absence of evidence that prophylactic availability enhances promiscuity, a strong case can be made for venereal disease prophylaxis. This paper reviews the efficacy and acceptability of prophylactic techniques. In the military, acceptability and efficacy have been demonstrated for systemic antibiotics, and probably a postcoital prophylactic kit. These measures are either inappropriate or unavailable for general civilian use. The condom and vaginal spermicides offer promise of partial protection; further studies of efficacy and utilization are needed.

Administration, Topical↗

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Sexual assault and physical health: findings from a population-based study of older adults.

OBJECTIVE: Prior reports have pointed to an adverse effect of sexual assault on subsequent health, particularly depression and obesity, in women. The objective of this study was to determine whether there is an association between self-reported sexual assault history and objective parameters of physical health in a sample of older men and women. METHODS: We conducted a cross-sectional study of white, middle to upper middle class, older (median age 75 years) men (N = 533) and women (N = 826) within a defined community setting. Sex-specific, age-adjusted risks were calculated for 11 common chronic medical conditions (10 for each sex: coronary heart disease, hypertension, diabetes, osteoporosis, obesity, asthma, migraine, thyroid disease, and arthritis in all subjects; breast cancer in women; and prostate cancer in men) and confirmed by physical or laboratory examination or review of medical records. RESULTS: Sexual assault was reported by 5.4% of men and 12.7% of women; repeated exposure was reported by 10.3 and 21.9% of sexually assaulted men and women, respectively. In women, a history of sexual assault was associated with an increased risk of 2 of 10 conditions: arthritis (OR = 1.76, 95% CI = 1.13-2.76) and breast cancer (OR = 2.21, 95% CI = 1.12-4.33). A "dose-response" effect was observed: Multiple episodes of sexual assault carried a two- to three-fold increased risk of these diseases compared with a single episode. In men, the only statistically significant association was between sexual assault and thyroid disease (OR = 4.68, 95% CI = 1.08-20.3). CONCLUSIONS: These data partially replicate findings from other studies of adverse effects of sexual trauma on health, although the specific diseases are different. Causal mechanisms cannot be inferred from these data. Studies in other cohorts are warranted.

Aged↗

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The North American Menopause Society 1998 menopause survey: Part II. Counseling about hormone replacement therapy: association with socioeconomic status and access to medical care.

OBJECTIVE: The purpose of this study was to examine two predictors of women's obtaining hormone replacement therapy (HRT) counseling: socioeconomic status and access to health care. DESIGN: During May-July 1998, by means of random-digit telephone dialing, 749 postmenopausal women who were living in the United States and aged 50-65 years were interviewed. On average, they were 56.8 years and 11.8 years postmenopausal. Most (86.0%) were Caucasian, and their median annual income was approximately $40,000. Nearly all (90.8%) had medical insurance coverage; 47.6% of those insured received care from a managed care organization. Access to medical care was evidenced by 92.3% being under the care of a primary care physician, 92.3% ever having had a mammogram, 96.9% ever having had a pelvic examination, and 91.1% ever having had a serum cholesterol determination. RESULTS: Of these 749 women, 75.4% reported that they had received counseling about post-menopausal HRT from healthcare providers. Both level of education and level of income were associated with an increased likelihood that HRT counseling would be obtained. Having a personal physician, and particularly receiving care from a gynecologist, increased the likelihood that counseling would be available. There were no substantial differences in counseling frequency between women in managed care plans and those having other types of health insurance. In a multivariate model, adjusted odds ratios for receiving HRT counseling were 2.9 (95% confidence interval [CI] = 1.7-4.8) for having an annual income of $50,000 or more versus less than $30,000, 2.8 (95% CI = 1.7-4.5) for receiving care from a gynecologist versus other primary care physician, 1.9 (95% CI = 1.1-3.2) for being Caucasian versus not, and 1.5 (95% CI 1.0-2.2) for having a hysterectomy versus not. CONCLUSIONS: Three quarters of a sample of US postmenopausal women aged 50-65 years reported that they had been counseled about HRT. However, women of lowest socioeconomic status and those who did not have a primary care physician were least likely to have received counseling. No differences were observed in prevalence of counseling between women in managed care settings and those with other types of health insurance. The findings suggest that special efforts are necessary to provide menopause education and counseling to underserved women.

Counseling↗

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Ischemic heart disease risk in postmenopausal women. Effects of estrogen use on glucose and insulin levels.

We report the fasting and post-challenge plasma insulin and glucose levels in 469 nondiabetic postmenopausal women from the Rancho Bernardo cohort according to the current use of estrogen replacement therapy. In these older women, the use of noncontraceptive estrogen was not associated with impaired glucose tolerance. Estrogen-treated women had lower levels of insulin than women who were not taking estrogen; these differences were not explained by age, obesity, or differential hormone use by women with known glucose intolerance. There were no significant differences in glucose and insulin levels in those taking conjugated equine estrogen (Premarin) alone compared to those taking it with medroxyprogesterone acetate (Provera).

Aged↗

PubMedDate not supplied

Endogenous sex hormones, high density lipoprotein cholesterol, and other lipoprotein fractions in men.

At least some of the large preponderance for coronary heart disease in men has been attributed to differences in lipid and lipoprotein levels; notably, high density lipoprotein cholesterol (HDL-C), a protective factor, is higher in women. The sex differences in lipid levels have been postulated to be related to differences in sex hormones. In a southern California cohort of 391 men aged 30-79 years, HDL-C levels were positively correlated and very low density lipoprotein cholesterol (VLDL-C) levels were inversely correlated with testosterone levels independently of age, body mass index, physical exercise, smoking, and alcohol intake. Mean HDL-C levels were 12% higher and VLDL-C levels were 40% lower in the highest compared with the lowest quartile of testosterone level. Low density lipoprotein cholesterol levels were positively related to estrone, estradiol, and androstenedione levels. It is premature to attribute the sex differential in lipid cardiovascular risk profiles to higher levels of testosterone per se in men, since testosterone levels are favorably associated with cardiovascular risk while estrogen levels have the converse relation in men. The differing effects and interactions of specific endogenous sex hormones in men and women require further elucidation.

Adult↗