Primary Care Providers' Experiences Recommending and Performing Cervical Cancer Screening for Women with Intellectual Disabilities: A Qualitative Study.

Women with intellectual and developmental disabilities (I/DD) are less likely to receive cervical cancer screening (CCS) relative to women without disabilities. Primary care providers (PCPs) play key roles in recommending CCS. The purpose of this study was to identify factors PCPs consider when recommending and performing CCS for women with I/DD. Using a qualitative approach, in-depth semi-structured interviews (N = 13) were conducted with majority family medicine-trained PCPs. Through inductive data analysis, it was found that most PCPs reported recommending CCS; however, follow-through for performing CCS varied. PCPs attempted to align their CCS recommendations with national guidelines and provided counseling and education to families and patients about CCS while taking an individualized risk-benefit approach. Despite most PCPs reporting a lack of knowledge or training related to providing I/DD-specific care, PCPs attempted to draw upon experiences with similar populations to recommend and perform CCS. There is an opportunity to improve knowledge of PCPs related to performing CCS for women with I/DD.

Are Researchers Addressing Cancer Treatment and Survivorship Among People With Intellectual and Developmental Disabilities in the U.S.? A Scoping Review.

People with intellectual and developmental disabilities (PWIDD) often encounter barriers in the health care system when seeking general and specialized medical care. Literature has shown that PWIDD experience a lack of proper screening for and prevention of cancer compared to the general population. However, less is known regarding the cancer care and survivorship of PWIDD, especially in the United States. In this review, we examine what is currently known about the primary, psychosocial, and palliative care of PWIDD diagnosed with cancer. Our analyses reveal an immediate need for improvement in caregiver support, collaboration among health care providers, and ethical approaches to information disclosure for this population, as well as the establishment of more reliable standards of care through additional research with PWIDD.

Providing Equitable Access to Health Care for Individuals with Disabilities: An Important Challenge for Medical Education.

In a recent national survey, over 50% of physicians reported not feeling confident in their ability to provide care to individuals with disabilities. This finding is troubling as physicians are required by the Americans with Disabilities Act (1990) to ensure their practice is accessible to individuals with disabilities. This commentary addresses the need for including disability in medical education and to provide inclusive and quality care for individuals with disabilities. We offer four recommendations to enhance medical school curricula that would educate medical students to provide equitable health services to individuals with disabilities: 1) embed disability training throughout medical education; 2) educate medical students to recognize multiple models of disability; 3) include education and experience with universal design and supported decision-making; and 4) include individuals with all types of disabilities in medical education. Including disability education for medical students should better prepare future physicians for feeling confident in their ability to provide care to individuals with disabilities.

Body composition and physical function in the Women's Health Initiative Observational Study.

Physical function is critical for mobility and quality of life. We hypothesized that higher total lean mass is associated with higher physical function, and body fat inversely associated, among postmenopausal women. Women's Health Initiative Observational Study participants at Pittsburgh, PA; Birmingham, AL; and Tucson-Phoenix, AZ (1993-1998) completed dual-energy X-ray absorptiometry scans and the Rand SF-36 questionnaire at baseline and 3 y (N = 4526). Associations between quartiles (Q1-4) of lean or fat mass and physical function were tested using linear regression, adjusted for demographics, lifestyle factors, medical history, and scanner serial number. At baseline, participants had a mean ±â€¯SD age of 63.4 ±â€¯7.4 y and BMI of 27.4 ±â€¯5.8 kg/m2. Higher percent lean mass was positively associated with physical function at baseline (Q4, 83.6 ±â€¯0.6 versus Q1, 74.6 ±â€¯0.7; p < 0.001), while fat mass (kg and %) was inversely associated (e.g., Q4, 73.7 ±â€¯0.7 versus Q1, 84.2 ±â€¯0.7 kg; ptrend < 0.001). Physical function had declined across the cohort at 3 y; the highest relative lean mass quartile at baseline conferred a lesser decline in physical function than the lowest (Q4, -3.3 ±â€¯0.6 versus Q1-7.0 ±â€¯0.6; ptrend < 0.001), while the highest fat mass quartile (% and kg) conferred greater decline (ex. Kg Q4, -6.7 ±â€¯0.7 versus Q1-2.8 ±â€¯0.6; ptrend < 0.001). Increased fat mass (≥5%), but not lean mass, was associated with lower physical function at 3 y (p < 0.001). Adiposity, as well as lean mass, requires consideration in the prediction of physical function among postmenopausal women over time.

Rheumatoid arthritis is associated with less optimal hip structural geometry.

The overall goal of this study was to assess the longitudinal changes in bone strength in women reporting rheumatoid arthritis (RA; n=78) compared with nonarthritic control participants (n=4779) of the Women's Health Initiative bone mineral density (WHI-BMD) subcohort. Hip structural analysis program was applied to archived dual-energy X-ray absorptiometry scans (baseline, years 3, 6, and 9) to estimate bone mineral density (BMD) and hip structural geometry parameters in 3 femoral regions: narrow neck (NN), intertrochanteric (IT), and shaft (S). The association between RA and hip structural geometry was tested using linear regression and random coefficient models. Compared with the nonarthritic control, the RA group had a lower BMD (p=0.061) and significantly lower outer diameter (p=0.017), cross-sectional area (p=0.004), and section modulus (p=0.035) at the NN region in the longitudinal models. No significant associations were seen at the IT regions or S regions, and the association was not modified by age, ethnicity, glucocorticoid use, or time. Within the WHI-BMD, women with RA group had reduced BMD and structural geometry at baseline, and this reduction was seen at a fixed rate throughout the 9 yr of study.

Calcium plus vitamin D supplementation has limited effects on femoral geometric strength in older postmenopausal women: the Women's Health Initiative.

Calcium plus vitamin D (CaD) supplementation has a modest but significant effect on slowing loss of femoral bone mass and reducing risk of hip fractures in adherent postmenopausal women. The goal of this study was to determine if CaD supplementation influences hip structural parameters that are associated with fracture risk. We studied 1,970 postmenopausal women enrolled in the Women's Health Initiative randomized controlled trial of CaD at one of three bone mineral density (BMD) clinical centers. Hip structural analysis software measured BMD and strength parameters on DXA scans at three regions: femoral narrow neck, intertrochanter, and shaft. Random effects models were used to test the average differences in hip BMD and geometry between intervention and placebo. There was greater preservation of hip BMD at the narrow neck with CaD relative to placebo across 6 years of intervention. CaD also altered the underlying cross-sectional geometry at the narrow neck in the direction of greater strength, with small increases in cross-sectional area and section modulus and a decrease in buckling ratio with CaD relative to placebo. While trends at both the intertrochanter and shaft regions were similar to those noted at the narrow neck, no significant intervention effects were evident. There was no significant interaction of CaD and age or baseline calcium levels for hip structural properties. CaD supplementation is associated with modest beneficial effects on hip structural features at the narrow neck, which may explain some of the benefit of CaD in reducing hip fracture risk.

Effect of hormone therapy on lean body mass, falls, and fractures: 6-year results from the Women's Health Initiative hormone trials.

OBJECTIVE: Loss of lean body mass with aging may contribute to falls and fractures. The objective of this analysis was to determine if taking postmenopausal hormone therapy (or HT: estrogen plus progestogen therapy or estrogen therapy alone) favorably affects age-related changes in lean body mass and if these changes partially account for decreased falls or fractures with HT. METHODS: Participants randomly assigned to either estrogen plus progestogen therapy (n = 543) or control (n = 471) and estrogen therapy alone (n = 453) or control (n = 474) and receiving dual-energy x-ray absorptiometry scans to estimate body composition during the Women's Health Initiative were evaluated. Falls and fracture occurrence were obtained by annual self-report. Fractures were confirmed by a clinical chart review. RESULTS: At 6 years postrandomization, lean body mass was not different between HT and control groups. Although lean body mass positively influenced bone mineral density, independent of HT status, the preserved lean body mass observed in the HT arms in the first 3 years did not significantly contribute to models evaluating HT influence on falls and fractures between years 3 and 6. Women taking at least 80% of their medication in the HT arms demonstrated fewer falls compared with placebo; this difference was not attributable to change in lean body mass. CONCLUSIONS: Despite early preservation of lean body mass with HT (3 y), HT did not ameliorate long-term (6 y) loss in lean body mass with aging.

The relationship between incidence of fractures and anemia in older multiethnic women.

OBJECTIVES: To prospectively examine the relationship between anemia and incident fractures of the hip, spine, and all skeletal sites in women from diverse racial and ethnic backgrounds enrolled in the Women's Health Initiative (WHI) Observational Study and Clinical Trials. DESIGN: Prospective cohort study. SETTING: Forty WHI clinical centers across the United States. PARTICIPANTS: Postmenopausal women (n=160,080), mean age 63.2±7.2, were recruited and followed for an average of 7.8 years. MEASUREMENTS: Anemia was defined as hemoglobin levels at baseline less than 12 g/dL. All fractures were self-reported. Trained physicians further confirmed hip fractures using medical records. RESULTS: Eight thousand seven hundred thirty-nine of the participants (5.5%) were anemic. The age-adjusted incidence rate of hip fractures per 10,000 person-years was 21.4 in women with anemia and 15.0 in women without anemia; higher incidence rates for spine and all fractures were also observed in anemic women. After multiple covariates were included in the Cox proportional hazards models, significantly greater fracture risk associated with anemia still existed, as demonstrated by hazard ratios of fractures associated with anemia of 1.38 (95% confidence interval (CI)=1.13-1.68) for hip, 1.30 (95% CI=1.09-1.55) for spine, and 1.07 (95% CI=1.01-1.14) for all types. No significant racial or ethnic difference was found in these relationships. CONCLUSION: A significantly greater fracture risk was observed in multiethnic postmenopausal women with anemia. Given the high prevalence of anemia in the elderly population, it is important to better understand the relationship and mechanisms linking anemia to fracture risk.

Hormone therapy improves femur geometry among ethnically diverse postmenopausal participants in the Women's Health Initiative hormone intervention trials.

Loss of bone strength underlies osteoporotic fragility fractures. We hypothesized that hormone interventions significantly improve the structural geometry of proximal femur cross-sections. Study participants were from the Women's Health Initiative hormone intervention trials: either the conjugated equine estrogen (CEE) only (N(placebo) = 447, N(CEE) = 422) trial or the estrogen (E) plus progestin (P) (N(placebo) = 441, N(E+P) = 503) trial, who were 50-79 yr old at baseline and were followed up to 6 yr. BMD scans by DXA were conducted at baseline, year 1, year 3, and year 6. Femur geometry was derived from hip DXA scans using the hip structural analysis (HSA) method. Mixed effects models with the intent-to-treat analysis approach were used. There were no significant differences in treatment effects between the E-alone and the E + P trial, so the analyses were conducted with participants combined from both trials. Treatment benefits (p < 0.05) on femur geometry were observed as early as 1 yr after the intervention. From baseline to year 6, section modulus (a measure of maximum bending stress) was preserved, and buckling ratio (an index of cortical instability under compression) was reduced by hormone interventions (p < 0.05); the differences in the percent changes from baseline to year 6 between women on hormone intervention versus women on placebo were 2.3-3.6% for section modulus and -5.3% to - 4.3% for buckling ratio. Hormone interventions led to favorable changes in femur geometry, which may help explain the reduced fracture risk observed in hormone interventions.

Dual-energy X-ray absorptiometry is a valid tool for assessing skeletal muscle mass in older women.

Assessing skeletal muscle mass (SMM) is critical in studying and detecting sarcopenia. Direct measurements by MRI or computerized tomography are expensive or high in radiation exposure. Dual-energy X-ray absorptiometry (DXA) is promising for body composition assessments, but the validity of DXA for predicting SMM in the elderly is still under investigation. The objective of this study was to assess the relationship between DXA-derived measurements of lean soft tissue mass (LSTM) and SMM in older women. Study participants were postmenopausal women (n = 101) recruited in southern Arizona. Total and regional body composition was measured using MRI and DXA (QDR4500w). The participants' mean age was 70.7 +/- 6.4 y and their mean BMI was 27.4 +/- 5.1 kg/m2. DXA-derived LSTM was highly correlated with MRI-derived SMM for the whole body (r = 0.94; P < 0.001) and leg region (r = 0.91; P < 0.001). In multivariate models, adjusting for age and DXA-derived percent fat slightly increased the amount of variance in SMM that can be explained by the DXA-derived LSTM assessments for the leg region but not for the total body. In conclusion, although the relationships between DXA measures and MRI-derived SMM vary by region of interest, the overall prediction of SMM by DXA is excellent. We conclude that DXA is a reliable method for cross-sectional assessments of SMM in older women.

Benchmarks for designing two-stage studies using modified mini-mental state examinations: experience from the Women's Health Initiative Memory Study.

BACKGROUND: The most efficient approach for studies examining the incidence of dementia involves a brief screening instrument to identify participants for more extensive testing to identify cognitive impairment. The modified mini-mental state examination (3MS) is commonly used as this initial screen in such two-stage designs, however its properties for this role require further study. PURPOSE: We use data from the Women's Health Initiative Memory Study to contrast design options in two-stage designs. METHODS: This trial enrolled 7251 participants with nine or more years of education who were aged 65-79 and followed an average of four to five years. Logistic regression was used to examine the case yields at varying two-stage 3MS cutpoints. The efficiency of using different examination schedules and restricting enrollment to higher risk women was examined. RESULTS: Probable dementia is associated with marked decline in 3MS scores. The percentages of women classified with probable dementia ranged from 7.95% (3MS 85-88) to 50.0% (3MS < 70). The numbers [95% confidence interval] of enrolled women necessary to detect one case of probable dementia (four-year follow-up) for baseline 3MS scores of 100, 95, 90 and 85 were estimated as 1477 [389, 5618], 253 [134, 481], 53 [34, 85], and 14 [9, 23], respectively. Compared to annual testing, administration every two years increased the number of required enrollees by 11%, but decreased the number of test administrations by 46%. LIMITATIONS: Our findings are influenced by the characteristics of our study group, its rates of retention, and the study protocol, and may not fully generalize to other settings. CONCLUSIONS: The 3MS can serve as an efficient basis for two-stage study designs and a cutpoint of < or = 88 is reasonable for populations with similar characteristics. Studies may improve efficiency by using the 3MS during screening to eliminate women with low risk for dementia and by conducting testing every two years.

Effects of conjugated equine estrogen on risk of fractures and BMD in postmenopausal women with hysterectomy: results from the women's health initiative randomized trial.

UNLABELLED: Further analyses from the Women's Health Initiative estrogen trial shows that CEE reduced fracture risk. The fracture reduction at the hip did not differ appreciably among risk strata. These data do not support overall benefit over risk, even in women at highest risk for fracture. INTRODUCTION: The Women's Health Initiative provided evidence that conjugated equine estrogen (CEE) can significantly reduce fracture risk in postmenopausal women. Additional analysis of the effects of CEE on BMD and fracture are presented. MATERIALS AND METHODS: Postmenopausal women 50-79 years of age with hysterectomy were randomized to CEE 0.625 mg daily (n = 5310) or placebo (n = 5429) and followed for an average 7.1 years. Fracture incidence was assessed by semiannual questionnaire and verified by adjudication of radiology reports. BMD was measured in a subset of women (N = 938) at baseline and years 1, 3, and 6. A global index was used to examine whether the balance of risks and benefits differed by baseline fracture risk. RESULTS: CEE reduced the risk of hip (hazard ratio [HR], 0.65; 95% CI, 0.45-0.94), clinical vertebral (HR, 0.64; 95% CI, 0.44-0.93), wrist/lower arm (HR, 0.58; 95% CI, 0.47-0.72), and total fracture (HR, 0.71; 95% CI, 0.64-0.80). This effect did not differ among strata according to age, oophorectomy status, past hormone use, race/ethnicity, fall frequency, physical activity, or fracture history. Total fracture reduction was less in women at the lowest predicted fracture risk in both absolute and relative terms (HR, 0.86; 95% CI, 0.68-1.08). CEE also provided modest but consistent positive effects on BMD. The HRs of the global index for CEE were relatively balanced across tertiles of summary fracture risk (lowest risk: HR, 0.81; 95% CI, 0.62-1.05; mid risk: HR, 1.09; 95% CI, 0.92-1.30; highest risk: HR, 1.04; 95% CI, 0.88-1.23; interaction, p = 0.42). CONCLUSIONS: CEE reduces the risk of fracture and increases BMD in hysterectomized postmenopausal women. Even among the women with the highest risk for fractures, when considering the effects of estrogen on other important health outcomes, a summary of the burden of monitored effects does not indicate a significant net benefit.

Calcium plus vitamin D supplementation and the risk of fractures.

BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal. METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers. RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels. CONCLUSIONS: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

Calcium plus vitamin D supplementation and the risk of colorectal cancer.

BACKGROUND: Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials. However, randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 36,282 postmenopausal women from 40 Women's Health Initiative centers: 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [corrected] twice daily (1000 mg of elemental calcium and 400 IU of vitamin D3) and 18,106 received a matching placebo for an average of 7.0 years. The incidence of pathologically confirmed colorectal cancer was the designated secondary outcome. Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study. RESULTS: The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo (168 and 154 cases; hazard ratio, 1.08; 95 percent confidence interval, 0.86 to 1.34; P=0.51), and the tumor characteristics were similar in the two groups. The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups. There were no significant treatment interactions with baseline characteristics. CONCLUSIONS: Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women. The long latency associated with the development of colorectal cancer, along with the seven-year duration of the trial, may have contributed to this null finding. Ongoing follow-up will assess the longer-term effect of this intervention. (ClinicalTrials.gov number, NCT00000611.).

Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial. OBJECTIVE: To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States. INTERVENTIONS: Participants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern. MAIN OUTCOME MEASURE: Invasive colorectal cancer incidence. RESULTS: A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention. CONCLUSION: In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. OBJECTIVE: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. INTERVENTION: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. MAIN OUTCOME MEASURES: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). RESULTS: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. CONCLUSIONS: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Postmenopausal hormone therapy and body composition--a substudy of the estrogen plus progestin trial of the Women's Health Initiative.

BACKGROUND: It has been suggested that hormone therapy may help counter undesirable changes in body composition in older women. OBJECTIVE: This study was designed to test whether estrogen plus progestin (E+P) therapy favorably affects age-related changes in body composition in postmenopausal women. DESIGN: The substudy was composed of 835 women from the estrogen plus progestin trial of the Women's Health Initiative who were randomly assigned to receive either E+P therapy (n = 437) or placebo (n = 398). The women had a mean age of 63.1 y and, on average, were 13.8 y past menopause. More than 17% of the participants were from an ethnic minority. No significant differences in baseline body composition (measured with dual-energy X-ray absorptiometry) by intervention assignment were observed. RESULTS: After 3 y of intervention, the women who received active E+P therapy lost less lean soft tissue mass (-0.04 kg) than did the women who received placebo (-0.44 kg; P = 0.001). Additionally, the women in the E+P group had less upper-body fat distribution than did the women in the placebo group (change in ratio of trunk to leg fat mass: -0.025 for the E+P group and 0.004 for the placebo group; P = 0.003). A sensitivity analysis, which was conducted on the women who took > or = 80% of the study medication during the intervention period, corroborated the findings from the intent-to-treat analysis. CONCLUSIONS: A 3-y E+P intervention significantly reduced both the loss of lean soft tissue mass and the ratio of trunk to leg fat mass in postmenopausal women. However, the effect sizes were small, and whether these changes in body composition lead to significant health benefits remains to be confirmed.

Osteoporosis and rate of bone loss among postmenopausal survivors of breast cancer.

BACKGROUND: Breast cancer diagnosis and treatment may put women at higher risk for osteoporosis in later life. METHODS: In a subgroup of participants in the Women's Health Initiative Observational Study, authors of the current study investigated differences in bone mineral density (BMD, measured by dual-energy x-ray absorptiometry) between breast cancer survivors (n = 209) and a noncancer reference group (n = 5759). RESULTS: In comparison to the reference group, breast cancer survivors had significantly lower total body BMD value (0.989 vs. 1.013 g/cm(2), P = 0.001) and total hip BMD value (0.823 vs. 0.845 g/cm(2), P = 0.02) at baseline after adjustment for age, race/ethnicity, years since menopause, and clinical center. These lower BMD levels were largely explained by lower usage of hormone therapy (HT) among survivors: after additional statistical adjustment for HT, hip BMD values were 0.834 versus 0.844 g/cm(2) (P = 0.26), and total body values were 1.005 versus 1.013 g/cm(2) (P = 0.33) for survivors and reference women, respectively. More than 77% of survivors with osteoporosis were undiagnosed by their healthcare providers, and this was similar to the undiagnosed rate in the reference group (85.7%). Longitudinally, breast cancer survivors in this study did not demonstrate an accelerated rate of bone loss compared with the reference population. CONCLUSIONS: Associated with lower HT usage, postmenopausal survivors of breast cancer were more likely to have low BMD in comparison to other women of the same age; and many of these survivors with osteoporosis were undiagnosed.

Fracture risk among breast cancer survivors: results from the Women's Health Initiative Observational Study.

BACKGROUND: Breast cancer and its treatment may compromise bone health. We tested the hypothesis in the Women's Health Initiative Observational Study that postmenopausal survivors of breast cancer have a higher risk for fractures compared with women who have no cancer history. METHODS: A prospective cohort (5.1 years' follow-up) study design was used. Breast cancer survivors were women who reported a history of breast cancer (n = 5298). A reference group included women who had no cancer history at baseline (n = 80 848). Fracture occurrence was ascertained from annual self-reports. Hip fractures were confirmed by reviewing medical records. RESULTS: After adjustment for age, weight, ethnicity, and geographic region of enrollment, the hazard ratios (HRs) of breast cancer survivors to women in the reference group were 0.93 (95% confidence interval [CI], 0.64-1.33) for hip; 1.36 (95% CI, 1.16-1.59) for forearm or wrist; 1.31 (95% CI, 1.19-1.43) for eligible fractures other than hip, vertebral, and forearm or wrist; and 1.31 (95% CI, 1.21-1.41) for these fractures combined. The increased risk for clinical vertebral fracture was statistically significant only among survivors who had a breast cancer diagnosis before age 55 years (HR, 1.78; 95% CI, 1.28-2.46). After adjusting for factors related to hormone levels, risk of fall, fracture history, medication use, comorbidity, and lifestyle, the increased risk for all fractures studied among survivors was reduced to 15% (HR, 1.15; 95% CI, 1.05-1.25). CONCLUSIONS: Postmenopausal survivors of breast cancer are at increased risk for clinical fractures. Preventions and therapeutic interventions are needed to reduce fracture risk in this large and growing population.