A randomized controlled trial to reduce post-cessation weight gain.

BACKGROUND/OBJECTIVES: Weight gain is a barrier to smoking cessation. Previous interventions targeting weight gain while quitting smoking have largely been unsuccessful. The current study aimed to assess the efficacy of weight stability and weight loss interventions compared to a low-intensity, self-guided bibliotherapy weight management group. SUBJECTS/METHODS: A randomized controlled trial with 12-month follow-up from 2018 to 2022 was conducted with participants (N = 305) who reported smoking at least five cigarettes per day for the last year and interest in quitting initially recruited from the Memphis, TN, USA area. Recruitment was expanded nationally with the onset of the COVID-19 pandemic. Subsequently, 276 completed 12-month follow-up. INTERVENTIONS/METHODS: The Bibliotherapy group was provided a weight management book. Both the Stability and Loss groups met via telephone for eight weeks to learn strategies for maintaining/losing weight, respectively. All three groups then received the same six-week smoking cessation intervention, with six months of varenicline provided. RESULTS: Individuals in the Loss group lost more weight (-2.01 kg, SE = 1.58) than individuals in the Bibliotherapy group (+1.08 kg, SE = 1.49, p = 0.0004), while the Stability group (-0.30 kg, SE = 1.56) was not significantly different from the Bibliotherapy group (p = 0.17). Those in the Stability group did not gain a significant amount of weight. Participants in the Loss group did not gain back all weight lost after smoking cessation and ended the study approximately 2.01 kg lower than baseline. The Bibliotherapy group did not gain the amount of weight expected after cessation. There were no significant differences between groups related to self-reported smoking cessation at each time point except at eight-month follow-up (p = 0.005). CONCLUSIONS AND RELEVANCE: Results indicated the Stability and the Loss interventions were effective for preventing post-smoking cessation weight gain, with the Loss group having the benefit of sustained weight loss. These interventions may be helpful to implement to combat weight gain and potentially facilitate smoking cessation. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT03156660).

Association between 25-Hydroxyvitamin D and Metabolic Syndrome in Older Adults: The Health, Aging and Body Composition Study.

OBJECTIVE: Low 25-hydroxyvitamin D (25[OH]D) levels and metabolic syndrome (MetS) are prevalent among older adults; however, longitudinal studies examining 25(OH)D status and MetS are lacking. We explore the association of 25(OH)D levels with prevalent and incident MetS in white and black older adults. Research Design and Methods. A total of 1620 white and 1016 black participants aged 70-79 years from the Health ABC cohort with measured 25(OH)D levels and data on MetS and covariates of interest were examined. The association between 25(OH)D levels and prevalent MetS at baseline and incident MetS at 6-year follow-up was examined in whites and blacks separately using logistic regression adjusting for demographics, lifestyle factors, and renal function. RESULTS: At baseline, 635 (39%) white and 363 (36%) black participants had prevalent MetS. In whites, low 25(OH)D levels were associated with prevalent MetS (adjusted OR (95% CI), 1.85 (1.47, 2.34)) and 1.96 (1.46, 2.63) for 25(OH)D of 20-<30 and <20 vs. ≥30 ng/ml, respectively). The association was attenuated after adjustment for BMI but remained significant. No association was found between 25(OH)D levels and prevalent MetS in blacks. Among those without MetS at baseline (765 whites, 427 blacks), 150 (20%) whites and 87 (20%) blacks had developed MetS at 6-year follow-up. However, 25(OH)D levels were not associated with incident MetS in whites or blacks. CONCLUSION: In older adults, low 25(OH)D levels were associated with increased odds of prevalent MetS in whites but not in blacks. No association was observed between 25(OH)D levels and incident MetS in either whites or blacks.

Renal Sympathetic Denervation: A Comprehensive Review.

In 2017, the American College of Cardiology and American Heart Association released its updated blood pressure guidelines, redefining hypertension to be any systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥80 mm Hg. Among United States adults, these new parameters increased the prevalence of hypertension from 72.2 million (31.9%) to 103.3 million (45.6%) adults and decreased the rate of medication-controlled hypertension from 53.4% to 39% with the prevalence of resistant hypertension ranging from 12% to 18%. Results of the pivotal SPRINT trial showed that more intensive blood pressure control in diabetic patients decreased both cardiovascular events and all-cause mortality. However, even with ideal goals in mind, compliance remains an issue due to multiple causes, and approximately half of study participants had stopped taking their antihypertensive drug within a year. Renal sympathetic denervation is a process in which catheter-based techniques are used to ablate specific portions of the renal artery nerves with the goal of decreasing sympathetic nerve activity and reducing blood pressure. Several studies using renal artery denervation have already shown benefit in patients with resistant hypertension, and now newer trials are beginning to focus on those with stage II hypertension as an additional potential treatment population. This review will seek to summarize the current evidence surrounding renal artery denervation and discuss some of its future trials, current issues, and potential roles both in hypertension and other comorbidities.

Serial Bone Density Measurement and Incident Fracture Risk Discrimination in Postmenopausal Women.

Importance: Repeated bone mineral density (BMD) testing to screen for osteoporosis requires resources. For patient counseling and optimal resource use, it is important for clinicians to know whether repeated BMD measurement (compared with baseline BMD measurement alone) improves the ability to discriminate between postmenopausal women who will and will not experience a fracture. Objective: To assess whether a second BMD measurement approximately 3 years after the initial assessment is associated with improved ability to estimate fracture risk beyond the baseline BMD measurement alone. Design, Setting, and Participants: The Women's Health Initiative is a prospective observational study. Participants in the present cohort study included 7419 women with a mean (SD) follow-up of 12.1 (3.4) years between 1993 and 2010 at 3 US clinical centers. Data analysis was conducted between May 2019 and December 2019. Main Outcomes and Measures: Incident major osteoporotic fracture (ie, hip, clinical spine, forearm, or shoulder fracture), hip fracture, baseline BMD, and absolute change in BMD were assessed. The area under the receiver operating characteristic curve (AU-ROC) for baseline BMD, absolute change in BMD, and the combination of baseline BMD and change in BMD were calculated to assess incident fracture risk discrimination during follow-up. Results: Of 7419 participants, the mean (SD) age at baseline was 66.1 (7.2) years, the mean (SD) body mass index was 28.7 (6.0), and 1720 (23%) were nonwhite individuals. During the study follow-up (mean [SD] 9.0 [3.5] years after the second BMD measurement), 139 women (1.9%) experienced hip fractures, and 732 women (9.9%) experienced major osteoporotic fracture. In discriminating between women who experience hip fractures and those who do not, AU-ROC values were 0.71 (95% CI, 0.67-0.75) for baseline total hip BMD, 0.61 (95% CI, 0.56-0.65) for change in total hip BMD, and 0.73 (95% CI, 0.69-0.77) for the combination of baseline total hip BMD and change in total hip BMD. Femoral neck and lumbar spine BMD values had similar discrimination for hip fracture. For discrimination of major osteoporotic fracture, AU-ROC values were 0.61 (95% CI, 0.59-0.63) for baseline total hip BMD, 0.53 (95% CI, 0.51-0.55) for change in total hip BMD, and 0.61 (95% CI, 0.59-0.63) for the combination of baseline total hip BMD and change in total hip BMD. Femoral neck and lumbar spine BMD values had similar ability to discriminate between women who experienced major osteoporotic fracture and those who did not. Associations between change in bone density and fracture risk did not differ by subgroup, including diabetes, age, race/ethnicity, body mass index, or baseline BMD T score. Conclusions and Relevance: The findings of this study suggest that a second BMD assessment approximately 3 years after the initial measurement was not associated with improved discrimination between women who did and did not experience subsequent hip fracture or major osteoporotic fracture beyond the baseline BMD value alone and should not routinely be performed.

The association between weight-promoting medication use and weight gain in postmenopausal women: findings from the Women's Health Initiative.

OBJECTIVE: With the rise in obesity, there has been a concomitant increase in prescription medications associated with weight gain. The objective of this study is to quantify the magnitude of association between putative weight-promoting medications and 3-year weight change in a diverse cohort of postmenopausal women in the Women's Health Initiative (WHI). METHODS: This is a prospective observational cohort study, considering 40 sites in the WHI and a cohort of seventy six thousand two hundred fifty-two postmenopausal women aged 50-79 years, with weight measured at both baseline and 3 years, in the WHI-Observational Study. Body mass index (BMI) and waist circumference (WC) were measured at baseline and 3 years. An in-clinic medication inventory identified prescribed medications, including antidepressants, beta-blockers, insulin, and/or glucocorticosteroids. Generalized linear models evaluated if intermittent or persistent use of weight-promoting drugs was associated with increased BMI and WC during a 3-year follow up. RESULTS: Women with overweight or obesity at baseline were more likely to be taking antidepressants, beta-blockers, and/or insulin. Taking at least one putative weight-promoting medication was associated with a greater increase in BMI (0.37 vs 0.27 kg/m, P = 0.0045) and WC (1.10 cm vs 0.89 cm, P = 0.0077) over the course of 3 years compared to women not on these medications. Both BMI and WC increased with the number of weight-promoting drugs prescribed (P for trend per medication used < 0.00001 for both variables). Those who took either antidepressants or insulin, or a combination of antidepressants and beta-blockers, were most likely to have a significant increase in BMI compared to nonusers. CONCLUSIONS: Antidepressants, beta-blockers, and insulin were associated with weight gain in postmenopausal women. This information may help to inform clinical decision-making and efforts to mitigate medication-related weight gain. : Video Summary:http://links.lww.com/MENO/A617.

Video Summary:http://links.lww.com/MENO/A617.

Higher amounts of sedentary time are associated with short sleep duration and poor sleep quality in postmenopausal women.

STUDY OBJECTIVES: To evaluate the associations between sedentary time, total (total-PA), light (light-PA), moderate (MOD-PA), and vigorous (VIG-PA) physical activity with indices of sleep in postmenopausal women. METHODS: Baseline self-reported data from the Women's Health Initiative Observational Study (n = 75 074) were used in this cross-sectional analysis. Total-PA, light-PA, MOD-PA, and VIG-PA were categorized by metabolic equivalents of the activity (MET-hour [hr]/week [wk]) and were estimated using validated questionnaires. Sedentary time was categorized by hr/day and was estimated via questionnaire. Logistic regression was used to examine the associations between these variables and short sleep (≤6 hr/night), long sleep (≥10 hr/night), poor sleep quality, and insomnia symptoms after adjustment for age, race, socioeconomic status, body mass index, health status, depressive symptoms, smoking status, alcohol use, hormone therapy, and comorbidities. RESULTS: Higher sedentary time (>11 hr/day) was associated with higher odds of short sleep (odds ratio [OR] = 1.80, 95% confidence interval [CI]: 1.72-1.88), poor sleep quality (OR = 1.85, 95% CI: 1.74-1.97), and insomnia symptoms (OR = 1.56, 95% CI: 1.49-1.64). Light-PA (>0 MET-hr/wk) was associated with lower odds of short sleep (OR = 0.96, 95% CI: 0.92-1.00), and higher amounts of total-PA (OR = 0.90, 95% CI: 0.84-0.97), light-PA (OR = 0.94, 95% CI: 0.89-1.00), and MOD-PA (OR = 0.91, 95% CI: 0.86-0.97) were associated with lower odds of poor sleep quality. CONCLUSIONS: Our findings suggest that higher levels of light and moderate intensity physical activity are associated with better sleep quality, whereas higher amounts of sedentary time are associated with short sleep and lower quality sleep. Future studies should investigate the directionality of these associations and potential causal pathways.

Fit & quit: An efficacy trial of two behavioral post-cessation weight gain interventions.

While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7 kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Fit & Quit is a randomized, controlled efficacy trial that aims to examine the ability of a weight stability intervention and a weight loss intervention to reduce post-cessation weight gain. For this purpose, Fit & Quit will randomize participants to three conditions: (a) Small Changes, a weight gain prevention intervention; (b) Look AHEAD Intensive Lifestyle Intervention; and (c) a lower-intensity bibliotherapy intervention. All conditions will receive a highly efficacious behavioral (i.e., rate reduction skills, motivational interviewing) and pharmacological (i.e., varenicline) smoking cessation program. A total of 400 participants will be recruited and randomized to the three interventions. Participants will be recruited in waves, with 10 waves of approximately 40 participants per wave. The primary outcomes of this study include post-cessation weight gain and cessation status at 12-month follow-up. Fit & Quit will integrate and adapt the strongest evidence-based interventions available for weight management and smoking cessation. Fit & Quit is highly innovative in the areas of the target population, study design, and use of technology. For these reasons, we expect that Fit & Quit will make a significant public health contribution to curtailing the important cessation barrier of post-cessation weight gain.

Associations between ACE-Inhibitors, Angiotensin Receptor Blockers, and Lean Body Mass in Community Dwelling Older Women.

Studies suggest that ACE-inhibitors (ACE-I) and angiotensin receptor blockers (ARBs) may preserve skeletal muscle with aging. We evaluated longitudinal differences in lean body mass (LBM) among women diagnosed with hypertension and classified as ACE-I/ARB users and nonusers among Women's Health Initiative participants that received dual energy X-ray absorptiometry scans to estimate body composition (n=10,635) at baseline and at years 3 and 6 of follow-up. Of those, 2642 were treated for hypertension at baseline. Multivariate linear regression models, adjusted for relevant demographics, behaviors, and medications, assessed ACE-I/ARB use/nonuse and LBM associations at baseline, as well as change in LBM over 3 and 6 years. Although BMI did not differ by ACE-I/ARB use, LBM (%) was significantly higher in ACE-I/ARB users versus nonusers at baseline (52.2% versus 51.3%, resp., p=0.001). There was no association between ACE-I/ARB usage and change in LBM over time. Reasons for higher LBM with ACE-I/ARB use cross sectionally, but not longitundinally, are unclear and may reflect a threshold effect of these medications on LBM that is attenuated over time. Nevertheless, ACE-I/ARB use does not appear to negatively impact LBM in the long term.

Effects of oral conjugated equine estrogens with or without medroxyprogesterone acetate on incident hypertension in the Women's Health Initiative hormone therapy trials.

OBJECTIVE: The aim of the study was to determine the effect of menopausal hormone therapy on incident hypertension in the two Women's Health Initiative hormone therapy trials and in extended postintervention follow-up. METHODS: A total of 27,347 postmenopausal women aged 50 to 79 years were enrolled at 40 US centers. This analysis includes the subsample of 18,015 women who did not report hypertension at baseline and were not taking antihypertensive medication. Women with an intact uterus received conjugated equine estrogens (CEE; 0.625 mg/d) plus medroxyprogesterone acetate (MPA; 2.5 mg/d) (n = 5,994) or placebo (n = 5,679). Women with prior hysterectomy received CEE alone (0.625 mg/d) (n = 3,108) or placebo (n = 3,234). The intervention lasted a median of 5.6 years in the CEE plus MPA trial and 7.2 years in the CEE-alone trial with 13 years of cumulative follow-up until September 30, 2010. The primary outcome for these analyses was self-report of a new diagnosis of hypertension and/or high blood pressure requiring treatment with medication. RESULTS: During the CEE and CEE plus MPA intervention phase, the rate of incident hypertension was 18% higher for intervention than for placebo (CEE: hazard ratio [HR], 1.18; 95% CI, 1.09-1.29; CEE plus MPA: HR, 1.18; 95% CI, 1.09-1.27). This effect dissipated postintervention in both trials (CEE: HR, 1.06; 95% CI, 0.94-1.20; CEE plus MPA: HR, 1.02; 95% CI, 0.94-1.10). CONCLUSIONS: CEE (0.625 mg/d) administered orally, with or without MPA, is associated with an increased risk of hypertension in older postmenopausal women. Whether lower doses, different estrogen formulations, or transdermal route of administration offer lower risks warrant further study.

Interaction between Nonsteroidal Anti-inflammatory Drugs and Low-fat Dietary Intervention on Colorectal Cancer Incidence; the Women's Health Initiative (WHI) Dietary Modification Trial.

BACKGROUND: The Women's Health Initiative (WHI) Dietary Modification (DM) trial did not show that reductions in dietary fat accompanied by increases in vegetable and fruit consumption decrease the incidence of colorectal cancer. Secondary analyses suggested that aspirin use may modify the intervention effects of DM on colorectal cancer development, although a recent reanalysis including the postintervention period confirmed no main effect of the intervention on reducing colorectal cancer incidence Methods: We analyzed data from 48,834 postmenopausal women who were randomized into the low-fat DM (N = 19,540) or comparison (N = 29,294) group for an average 8.1 years and followed for an additional 9.4 years through August 31, 2014. Exposure to specific class(es) or strength(s) of nonsteroidal anti-inflammatory drugs (NSAIDs) was modeled at baseline and as time-dependent use through the 9-year clinic visit. A Cox proportional hazard model was employed to assess the association of the DM, medication use, and their interaction with colorectal cancer events. RESULTS: A total of 906 incident cases of colorectal cancer were identified during the intervention and postintervention periods. By both exposure models, we found that colorectal cancer incidence was not different in the DM from the comparison group among any type of NSAID users. None of the interactions with any category of NSAID use was statistically significant; however there was most modest evidence for an interaction (p = 0.07) with aspirin use at baseline (hazard ratio [HR] = 0.81, 95% confidence interval [CI], 0.60-1.11 for users; HR = 1.12, 95% CI, 0.97-1.30 for nonusers). Strength and duration of aspirin use at baseline did not alter the associations. CONCLUSION: Extended follow-up of women in the WHI DM trial did not confirm combined protective effects of aspirin and low-fat diet on colorectal cancer risk among the postmenopausal women.

The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial.

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long-term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long-term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. A total of 5145 persons aged 45 to 76 years with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were white, and the mean BMI was 36 kg/m2 . Weight loss over the intervention period (median 9.6 years) was 6.0% in ILI and 3.5% in DSE. A total of 731 participants had a confirmed incident fracture (358 in DSE versus 373 in ILI). There were no statistically significant differences in incident total or hip fracture rates between the ILI and DSE groups. However, compared to the DSE group, the ILI group had a statistically significant 39% increased risk of a frailty fracture (HR 1.39; 95% CI, 1.02 to 1.89). An intensive lifestyle intervention resulting in long-term weight loss in overweight/obese adults with DM was not associated with an overall increased risk of incident fracture but may be associated with an increased risk of frailty fracture. When intentional weight loss is planned, consideration of bone preservation and fracture prevention is warranted. © 2017 American Society for Bone and Mineral Research.

Time to Clinically Relevant Fracture Risk Scores in Postmenopausal Women.

BACKGROUND: Clinical practice guidelines recommend use of fracture risk scores for screening and pharmacologic treatment decisions. The timing of occurrence of treatment-level (according to 2014 National Osteoporosis Foundation guidelines) or screening-level (according to 2011 US Preventive Services Task Force guidelines) fracture risk scores has not been estimated in postmenopausal women. METHODS: We conducted a retrospective competing risk analysis of new occurrence of treatment-level and screening-level fracture risk scores in postmenopausal women aged 50 years and older, prior to receipt of pharmacologic treatment and prior to first hip or clinical vertebral fracture. RESULTS: In 54,280 postmenopausal women aged 50 to 64 years without a bone mineral density test, the time for 10% to develop a treatment-level FRAX score could not be estimated accurately because of rare incidence of treatment-level scores. In 6096 women who had FRAX scores calculated with bone mineral density, the estimated unadjusted time to treatment-level FRAX ranged from 7.6 years (95% confidence interval [CI], 6.6-8.7) for those aged 65 to 69, to 5.1 years (95% CI, 3.5-7.5) for those aged 75 to 79 at baseline. Of 17,967 women aged 50 to 64 with a screening-level FRAX at baseline, 100 (0.6%) experienced a hip or clinical vertebral fracture by age 65 years. CONCLUSIONS: Postmenopausal women with sub-threshold fracture risk scores at baseline were unlikely to develop a treatment-level FRAX score between ages 50 and 64 years. After age 65, the increased incidence of treatment-level fracture risk scores, osteoporosis, and major osteoporotic fracture supports more frequent consideration of FRAX and bone mineral density testing.

Long-term oral bisphosphonate use in relation to fracture risk in postmenopausal women with breast cancer: findings from the Women's Health Initiative.

OBJECTIVE: The aim of the study was to examine the association of long-term oral bisphosphonate use, compared with short-term use, with fracture risk among postmenopausal women with breast cancer. METHODS: We studied 887 postmenopausal women who were enrolled to the Women's Health Initiative from 1993 to 1998, diagnosed with breast cancer after enrollment, and reported current oral bisphosphonate use of 2 years or more on a medication inventory administered in 2008 to 2009. The outcome of any clinical fracture was ascertained by self-report on an annual study form; a subset of fractures was confirmed with medical records. Women were followed from completion of the medication inventory until 2014. The association between duration of bisphosphonate use reported on the medication inventory and fracture was estimated using multivariate Cox proportional hazards survival models that compared 4 to 7 years and 8 or more years of bisphosphonate use with 2 to 3 years of use. RESULTS: On average, women were 76 years of age and were followed for 3.7 (SD 1.1) years. There were 142 clinical fractures. In the multivariate-adjusted analysis for fracture risk factors, 8 or more years of bisphosphonate use was associated with higher risk of fracture compared with 2 to 3 years of use (hazard ratio, 1.67 [95% CI, 1.06-2.62]). There was no significant association of 4 to 7 years of use with fracture. CONCLUSIONS: Bisphosphonate use of 8 or more years was associated with higher risk of any clinical fracture compared with 2 to 3 years of use. Our findings raise concern about potential harm or decreased effectiveness of long-term bisphosphonate use on fracture risk. The findings warrant confirmatory studies.

Use of and interest in mobile health for diabetes self-care in vulnerable populations.

OBJECTIVE: We aimed to assess use of and interest in mobile health (mHealth) technology and in-person services for diabetes self-care in vulnerable populations. METHODS: We delivered a self-administered cross-sectional survey. Participants were recruited at two primary care practices (P1 and P2) with P1 located in a medically underserved area and P2 in an affluent suburb. Two-sample t-tests and chi-square tests were used with p < 0.05 significant. In addition, a secondary analysis was performed to analyse differences in use and interest in mHealth by age. RESULTS: Of 75 eligible patients, 60 completed the survey (80% response rate). P1 patients had significantly higher interest in three of five categories of in-person diabetes support services, one of four categories of health-related text messages (TM), and three of eight categories of mHealth applications (p < 0.05). Smartphone users reported higher interest in TM (p = 0.004) and mHealth applications for diabetes self-care (p = 0.004). Younger patients were more likely to have a smartphone (p < 0.006), use the Internet (p < 0.0012), use smartphone applications (p < 0.0004), and to be interested in using applications to manage their diabetes (p < 0.004). DISCUSSION: This study shows substantial patient interest in TM and mHealth applications for diabetes self-care and suggests that patients in underserved areas may have particularly high interest in using mHealth solutions in primary care. Younger patients and smartphone users were more likely to be interested in using applications to manage their diabetes. As more patients use smartphones, interest in using mHealth to support patient self-care and strengthen primary care infrastructure will continue to grow.

Baseline age and time to major fracture in younger postmenopausal women.

OBJECTIVE: This study aims to estimate the incidence of first hip or clinical vertebral fracture or major osteoporotic (hip, clinical vertebral, proximal humerus, or wrist) fracture in postmenopausal women undergoing their first bone mineral density (BMD) test before age 65 years. METHODS: We studied 4,068 postmenopausal women, aged 50 to 64 years without hip or clinical vertebral fracture or antifracture treatment at baseline, who were participating in the Women's Health Initiative BMD cohort study. BMD tests were performed between October 1993 and April 2005, with fracture follow-up through 2012. Outcomes were the time for 1% of women to sustain a hip or clinical vertebral fracture and the time for 3% of women to sustain a major osteoporotic fracture before initiating treatment, adjusting for clinical risk factors and accounting for competing risks. Women without osteoporosis and women with osteoporosis on their first BMD test were analyzed separately. RESULTS: During a maximum of 11.2 years of concurrent BMD and fracture follow-up, the adjusted estimated time for 1% of women to have a hip or clinical vertebral fracture was 12.8 years (95% CI, 8.0-20.4) for women aged 50 to 54 years without baseline osteoporosis, 7.6 years (95% CI, 4.8-12.1) for women aged 60 to 64 years without baseline osteoporosis, and 3.0 years (95% CI, 1.3-7.1) for all women aged 50 to 64 years with baseline osteoporosis. Results for major osteoporotic fracture were similar. CONCLUSIONS: Because of very low rates of major osteoporotic fracture, postmenopausal women aged 50 to 64 years without osteoporosis on their first BMD test are unlikely to benefit from frequent rescreening before age 65 years.

Calcium/vitamin D supplementation, serum 25-hydroxyvitamin D concentrations, and cholesterol profiles in the Women's Health Initiative calcium/vitamin D randomized trial.

OBJECTIVE: The objective of this study was to evaluate whether increased serum 25-hydroxyvitamin D3 (25OHD3) concentrations, in response to calcium/vitamin D (CaD) supplementation, are associated with improved lipids in postmenopausal women. METHODS: The parent trial was a double-blind, randomized, placebo-controlled, parallel-group trial designed to test the effects of CaD supplementation (1,000 mg of elemental calcium + 400 IU of vitamin D3 daily) versus placebo in postmenopausal women. Women from the general community, including multiple sites in the United States, were enrolled between 1993 and 1998. This cohort included 300 white, 200 African-American, and 100 Hispanic participants who were randomly selected from the Women's Health Initiative CaD trial. Serum 25OHD3 and lipid (fasting plasma triglycerides [TG], high-density lipoprotein cholesterol [HDL-C], and calculated low-density lipoprotein cholesterol [LDL-C]) levels were assessed before and after CaD randomization. RESULTS: There was a 38% increase in mean serum 25OHD3 concentrations after 2 years (95% CI, 1.29-1.47, P < 0.001) for women randomized to CaD (24.3 ng/mL postrandomization mean) compared with placebo (18.2 ng/mL). Women randomized to CaD had a 4.46-mg/dL mean decrease in LDL-C (P = 0.03). Higher concentrations of 25OHD3 were associated with higher HDL-C levels (P = 0.003), along with lower LDL-C and TG levels (P = 0.02 and P < 0.001, respectively). CONCLUSIONS: Supplemental CaD significantly increases 25OHD3 concentrations and decreases LDL-C. Women with higher 25OHD3 concentrations have more favorable lipid profiles, including increased HDL-C, lower LDL-C, and lower TG. These results support the hypothesis that higher concentrations of 25OHD3, in response to CaD supplementation, are associated with improved LDL-C.

Bone mineral density patterns in vitamin D deficient African American men with sickle cell disease.

OBJECTIVE: To describe bone mineral density (BMD) patterns by densitometry in adult African American (AA) men with sickle cell disease (SCD) who are vitamin D deficient (Vit DD). INCLUSION/EXCLUSION CRITERIA: All SCD phenotypes were eligible. Those with chronic renal failure or hyperparathyroidism were excluded. DATA COLLECTION: Demographics, body mass index and SCD genotype. LABORATORY: Albumin, ferritin, calcium, phosphorus, 25-hydroxy vitamin D and intact-parathyroid hormone were obtained. BMD, T and Z scores: T scores at the lumbar spine were used to categorize normal, osteopenia and osteoporosis based on World Health Organization criteria. STATISTICAL ANALYSES: Mean ± standard deviation was used to describe continuous data, whereas categorical data were described by counts and percentages. The χ test was used to analyze categorical variables; Student's t test or one-way analysis of variance, when appropriate, was used to compare continuous variables. Rates of osteopenia-osteoporosis were determined, and the parameter with 95% confidence interval (CI) of a proportion was constructed. All tests were 2-sided, and a P ≤ 0.05 was considered statistically significant. We used StatView Version 5.01 (SAS institute Inc, Cary, NC) for the statistical analysis. RESULTS: Seventy-eight AA men with SCD disease and Vit DD were enrolled in this study. We found that 42% of the men studied had low-BMD (osteopenia or osteoporosis) using T scores at the lumbar spine to establish densitometry strata. The prevalence of osteoporosis was 14%. CONCLUSIONS: A large proportion of adult AA men with SCD and Vit DD showed low BMD.

Association of BMD and FRAX score with risk of fracture in older adults with type 2 diabetes.

CONTEXT: Type 2 diabetes mellitus (DM) is associated with higher bone mineral density (BMD) and paradoxically with increased fracture risk. It is not known if low BMD, central to fracture prediction in older adults, identifies fracture risk in patients with DM. OBJECTIVE: To determine if femoral neck BMD T score and the World Health Organization Fracture Risk Algorithm (FRAX) score are associated with hip and nonspine fracture risk in older adults with type 2 DM. DESIGN, SETTING, AND PARTICIPANTS: Data from 3 prospective observational studies with adjudicated fracture outcomes (Study of Osteoporotic Fractures [December 1998-July 2008]; Osteoporotic Fractures in Men Study [March 2000-March 2009]; and Health, Aging, and Body Composition study [April 1997-June 2007]) were analyzed in older community-dwelling adults (9449 women and 7436 men) in the United States. MAIN OUTCOME MEASURE: Self-reported incident fractures, which were verified by radiology reports. RESULTS: Of 770 women with DM, 84 experienced a hip fracture and 262 a nonspine fracture during a mean (SD) follow-up of 12.6 (5.3) years. Of 1199 men with DM, 32 experienced a hip fracture and 133 a nonspine fracture during a mean (SD) follow-up of 7.5 (2.0) years. Age-adjusted hazard ratios (HRs) for 1-unit decrease in femoral neck BMD T score in women with DM were 1.88 (95% confidence interval [CI], 1.43-2.48) for hip fracture and 1.52 (95% CI, 1.31-1.75) for nonspine fracture, and in men with DM were 5.71 (95% CI, 3.42-9.53) for hip fracture and 2.17 (95% CI, 1.75-2.69) for nonspine fracture. The FRAX score was also associated with fracture risk in participants with DM (HRs for 1-unit increase in FRAX hip fracture score, 1.05; 95% CI, 1.03-1.07, for women with DM and 1.16; 95% CI, 1.07-1.27, for men with DM; HRs for 1-unit increase in FRAX osteoporotic fracture score, 1.04; 95% CI, 1.02-1.05, for women with DM and 1.09; 95% CI, 1.04-1.14, for men with DM). However, for a given T score and age or for a given FRAX score, participants with DM had a higher fracture risk than those without DM. For a similar fracture risk, participants with DM had a higher T score than participants without DM. For hip fracture, the estimated mean difference in T score for women was 0.59 (95% CI, 0.31-0.87) and for men was 0.38 (95% CI, 0.09-0.66). CONCLUSIONS: Among older adults with type 2 DM, femoral neck BMD T score and FRAX score were associated with hip and nonspine fracture risk; however, in these patients compared with participants without DM, the fracture risk was higher for a given T score and age or for a given FRAX score.

Fracture risk in men with congestive heart failure risk reduction with spironolactone.

OBJECTIVES: The purpose of this study was to determine whether spironolactone use is associated with fractures in men with congestive heart failure (CHF). BACKGROUND: In rats with aldosteronism, spironolactone preserves skeletal strength. However, in humans, the relationship of spironolactone to fractures is not known. METHODS: The medical records of all male patients with CHF from 1999 to 2005 treated at the Veterans Affairs Medical Center, Memphis, Tennessee, were reviewed (n = 4,735). Odds ratios with 95% confidence intervals of having a fracture associated with spironolactone use were estimated using conditional logistic regression. RESULTS: We identified 167 cases with a single-incident fracture and matched these by age and race to 668 control subjects without fractures. After adjustment for covariates, spironolactone use was inversely associated with total fracture (odds ratio: 0.575; 95% confidence interval: 0.346 to 0.955, p = 0.0324). CONCLUSIONS: The use of spironolactone is inversely associated with fractures in men with CHF.