Dietary Inflammatory Potential and Bone Outcomes in Midwestern Post-Menopausal Women.

Little is known about the inflammatory potential of diet and its relation to bone health. This cross-sectional study examined the association between the inflammatory potential of diet and bone-related outcomes in midwestern, post-menopausal women enrolled in the Heartland Osteoporosis Prevention Study (HOPS) randomized controlled trial. Dietary intake from the HOPS cohort was used to calculate Dietary Inflammatory Index (DII®) scores, which were energy-adjusted (E-DIITM) and analyzed by quartile. The association between E-DII and lumbar and hip bone mineral density (BMD) and lumbar trabecular bone scores (TBS; bone structure) was assessed using ANCOVA, with pairwise comparison to adjust for relevant confounders (age, education, race/ethnicity, smoking history, family history of osteoporosis/osteopenia, BMI, physical activity, and calcium intake). The cohort included 272 women, who were predominately white (89%), educated (78% with college degree or higher), with a mean BMI of 27 kg/m2, age of 55 years, and E-DII score of -2.0 ± 1.9 (more anti-inflammatory). After adjustment, E-DII score was not significantly associated with lumbar spine BMD (p = 0.53), hip BMD (p = 0.29), or TBS at any lumbar location (p > 0.05). Future studies should examine the longitudinal impact of E-DII scores and bone health in larger, more diverse cohorts.

Approaches to Recruitment of Postmenopausal Women for a Community-Based Study.

BACKGROUND: Few researchers have focused on the challenges of recruiting postmenopausal women for community-based research. Researchers have reported that multiple methods may be needed to recruit the required number of subjects. One contemporary approach to recruitment is use of Facebook. More studies are needed examining Facebook as a recruitment strategy. OBJECTIVE: The aim of the study was to examine which recruitment methods were most successful and cost-effective in recruiting postmenopausal women for a randomized controlled trial on bone loss. METHODS: Subjects were 276 postmenopausal women who had osteopenia and were within 5 years of menopause. Multiple methods were used to recruit women. To determine which methods were successful, women were asked how they learned about the study. Descriptive data were used to examine recruitment numbers as well as to determine the cost-effectiveness and enrollment efficiency of recruitment methods. RESULTS: Healthcare provider letters yielded the highest number of enrolled subjects (n = 58), followed by postcard mailings (n = 47), and Facebook posts (n = 44). Eleven subjects were referred by family and friends, five subjects were from newspaper or television, and two were from digital ads. Cost of recruitment per subject enrolled was highest with digital ads and postcard mailings. DISCUSSION: Recruitment could be more costly and time-consuming than anticipated. Recruitment using direct-targeted mailings, such as provider letters and postcards, was successful in our study and has been effective in previous studies reviewed. Facebook was successful for recruitment in our study and may continue to be useful for recruitment in the future, as the number of women accessing Facebook continues to increase.

Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women.

BACKGROUND: In the United States, over 34 million American post-menopausal women have low bone mass (osteopenia) which increases their risk of osteoporosis and fractures. Calcium, vitamin D and exercise are recommended for prevention of osteoporosis, and bisphosphonates (BPs) are prescribed in women with osteoporosis. BPs may also be prescribed for women with low bone mass, but are more controversial due to the potential for adverse effects with long-term use. A bone loading exercise program (high-impact weight bearing and resistance training) promotes bone strength by preserving bone mineral density (BMD), improving bone structure, and by promoting bone formation at sites of mechanical stress. METHODS/DESIGN: The sample for this study will be 309 women with low bone mass who are within 5 years post-menopause. Subjects are stratified by exercise history (≥2 high intensity exercise sessions per week; < 2 sessions per week) and randomized to a control or one of two treatment groups: 1) calcium + vitamin D (CaD) alone (Control); 2) a BP plus CaD (Risedronate); or 3) a bone loading exercise program plus CaD (Exercise). After 12 months of treatment, changes in bone structure, BMD, and bone turnover will be compared in the 3 groups. Primary outcomes for the study are bone structure measures (Bone Strength Index [BSI] at the tibia and Hip Structural Analysis [HSA] scores). Secondary outcomes are BMD at the hip and spine and serum biomarkers of bone formation (alkaline phosphase, AlkphaseB) and resorption (Serum N-terminal telopeptide, NTx). Our central hypothesis is that improvements in bone strength will be greater in subjects randomized to the Exercise group compared to subjects in either Control or Risedronate groups. DISCUSSION: Our research aims to decrease the risk of osteoporotic fractures by improving bone strength in women with low bone mass (pre-osteoporotic) during their first 5 years' post-menopause, a time of rapid and significant bone loss. Results of this study could be used in developing a clinical management pathway for women with low bone mass at their peak period of bone loss that would involve lifestyle modifications such as exercises prior to medications such as BPs. TRIAL REGISTRATION: Clinicaltrials.gov NCT02186600 . Initial registration: 7/7/2014.

An exercise intervention for breast cancer survivors with bone loss.

PURPOSE: (a) to determine if 110 postmenopausal breast cancer survivors (BCS) with bone loss who participated in 24 months of strength and weight training (ST) exercises had improved muscle strength and balance and had fewer falls compared to BCS who did not exercise; and (b) to describe type and frequency of ST exercises; adverse effects of exercises; and participants' adherence to exercises at home, at fitness centers, and at 36-month follow up. DESIGN: Findings reported are from a federally funded multicomponent intervention study of 223 postmenopausal BCS with either osteopenia or osteoporosis who were randomly assigned to an exercise (n=110) or comparison (n=113) group. METHODS: Time points for testing outcomes were baseline, 6, 12, and 24 months into intervention. Muscle strength was tested using Biodex Velocity Spectrum Evaluation, and dynamic balance using Timed Backward Tandem Walk. Adherence to exercises was measured using self-report of number of prescribed sessions attended and participants' reports of falls. FINDINGS: Mean adherence over 24 months was 69.4%. Using generalized estimating equation (GEE) analyses, compared to participants not exercising, participants who exercised for 24 months had significantly improved hip flexion (p=0.011), hip extension (p=0.0006), knee flexion (p<0.0001, knee extension (p=0.0018), wrist flexion (p=0.031), and balance (p=0.010). Gains in muscle strength were 9.5% and 28.5% for hip flexion and extension, 50.0% and 19.4% for wrist flexion and extension, and 21.1% and 11.6% for knee flexion and extension. Balance improved by 39.4%. Women who exercised had fewer falls, but difference in number of falls between the two groups was not significant. CONCLUSIONS: Many postmenopausal BCS with bone loss can adhere to a 24 month ST exercise intervention, and exercises can result in meaningful gains in muscle strength and balance. CLINICAL RELEVANCE: More studies are needed for examining relationships between muscle strength and balance in postmenopausal BCS with bone loss and their incidence of falls and fractures.

Vitamin D insufficiency and musculoskeletal symptoms in breast cancer survivors on aromatase inhibitor therapy.

Breast cancer survivors (BCSs) on aromatase inhibitor (AI) therapy often experience musculoskeletal symptoms (joint pain and stiffness, bone and muscle pain, and muscle weakness), and these musculoskeletal symptoms may be related to low serum levels of vitamin D. The primary purpose of this pilot exploratory study was to determine whether serum levels of 25-hydroxyvitamin D (25[OH]D) concentration were below normal (<30 ng/mL) in 29 BCSs on AI therapy and if musculoskeletal symptoms were related to these low vitamin D levels. The mean (SD) serum 25(OH)D level was 25.62 (4.93) ng/mL; 86% (n = 25) had levels below 30 ng/mL. Patients reported muscle pain in the neck and back, and there was a significant inverse correlation between pain intensity and serum 25(OH)D levels (r = -0.422; P < .05 [2 tailed]). This sample of BCSs taking AIs had below normal levels of serum 25(OH)D despite vitamin D supplements. This is one of the few studies to document a significant relationship between vitamin D levels and muscle pain in BCSs on AI therapy. Findings from this pilot study can be used to inform future studies examining musculoskeletal symptoms in BCSs on AI therapy and relationships with low serum levels of vitamin D.

Bone mineral density and bone turnover in postmenopausal women treated for breast cancer.

Chemotherapy and endocrine treatments for breast cancer are believed to increase risk of osteoporosis by causing early menopause in premenopausal women and by further depleting estrogen levels in postmenopausal women. Multivariate analyses were used to evaluate the contributions of 7 predictors (age, body mass index [BMI], family history of osteoporosis, months since menopause, past use of chemotherapy, and current use of tamoxifen or aromatase inhibitors) in explaining variability in bone mineral density (BMD) at the hip and the spine and bone turnover in 249 postmenopausal women who are breast cancer survivors. This report was an analysis of baseline data from a federally funded (1 R01 NR07743-01A1) intervention study on osteoporosis prevention. Mean age of the women was 58.5 years, and average BMI was 26.7 kg/m; 98% were white. All had measurable bone loss, 167 had chemotherapy, 76 were on tamoxifen, and 21 were on aromatase inhibitors. Women with higher BMI had higher BMD at the hip (P < .001) and the spine (P = .004). Women on tamoxifen had lower measures of bone formation (Alkphase B) (P < .001), suggesting less bone turnover, and higher BMD at the hip (P = .035). There was a trend for women who had received chemotherapy to have lower BMD at the spine (P = .06). The implications of these findings are discussed in the article.

Health behaviors in breast cancer survivors experiencing bone loss.

PURPOSE: To describe the baseline healthy lifestyle behaviors (dietary, calcium, vitamin D, caffeine and alcohol intake, smoking history, and physical activity) of postmenopausal breast cancer survivors (BCS); and to identify any relationship of healthy lifestyle behaviors with bone mineral density (BMD) at the forearm, total hip and spine, L1-L4. DATA SOURCES: Self-reported responses to a demographic and health status questionnaire, to a 3-day Diet Record, and to the 7-Day Physical Activity Questionnaire-Adapted provided data for the lifestyle behaviors. Baseline BMD (g/cm(2)) was determined with dual-energy x-ray absorptiometry (DEXA). Height, weight, and body mass index (BMI) were also measured in each of the 249 postmenopausal BCS. CONCLUSIONS: There was an imbalance between consumed kilocalories and expenditure of energy. The majority of BCS were overweight or obese. They consumed less fruit and vegetable servings than recommended by the new 2005 U.S. Department of Agriculture's dietary guidelines, less dairy products, below average recommended grains and fiber, less protein and carbohydrate intake, and a slightly higher fat gram intake. Approximately, 43% did not take any supplemental calcium, with 46% taking less than 1000 mg a day. Likewise, 52.59% consumed less than 400 IU of vitamin D with both supplemental and dietary intake. This group of BCS consumed below accepted levels of caffeine and alcohol. Only 18 BCS continued to smoke. This group spent an average of 10.36 h in light (sedentary) activities on a daily basis. There were significant negative relationships with bone mass (g/cm(2)) at the total hip and daily intake of caffeine/mg and daily grams of alcohol. Weight and BMI both demonstrated a significant relationship with bone mass (g/cm(2)) at the total hip, spine L1-L4, and the forearm. IMPLICATIONS FOR PRACTICE: The healthcare provider must incorporate appropriate teaching strategies, intensive counseling, and coaching, along with a support mechanism, to enable BCS to understand the importance of a healthy diet, calcium, and vitamin D supplement, and a regular strength/weight program that will be integrated into their daily lifestyle. Early DEXA screens should be part of the protocol with BCS, and there is a particular need for forearm DEXA screens to be included in the treatment protocol for BCS.

Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention.

Recruitment of participants was a challenging issue for a statewide, 4-site, randomized, longitudinal trial for osteoporosis prevention. The accrual goal was 273 healthy breast cancer survivors. This federally funded study included a home-based followed by a fitness center-based 24-month intervention with follow-up at 36 months. In this report, recruitment planning, monitoring, and modifications are described, and the cost per enrolled participant is identified. Monthly monitoring of accrual numbers per recruitment strategy at each of 4 catchment areas allowed for early identification of necessary changes in recruitment strategies. Modifications were necessary when only 39% of the overall accrual goal had been attained at the 66% time point into the 18-month recruitment phase. Successful recruitment strategies were intensified, and new strategies were implemented, addressing motivators and deterrents for participation in clinical trials. Because approximately 81% of women were demonstrating bone loss via free dual energy x-ray absorptiometry screening, prevalence of the bone loss problem in survivors was incorporated into the recruitment information. Of 708 women screened via telephone and laboratory/dual energy x-ray absorptiometry testing, 249 were enrolled with 67% at 2 metropolitan sites and 33% at 2 rural sites. Recruitment media costs were approximately US$35 per enrolled participant. When combined with skeletal and laboratory screening, costs were approximately US$480 per enrolled participant. Tracking recruitment efforts in large clinical trials should be ongoing, site-specific, and cost-effective. Changes incorporated early in the recruitment phase addressed unique aspects of rural versus metropolitan areas and resulted in near achievement of accrual goals.

Facilitative strategies, psychological factors, and strength/weight training behaviors in breast cancer survivors who are at risk for osteoporosis.

INTRODUCTION/PURPOSE: Many women who have been treated for breast cancer are at increased risk for bone loss. Strength/weight training exercises (SWTE) may be effective in preventing bone loss and subsequent fractures. The purpose of this exploratory study was to examine psychological factors (self-efficacy, perceived benefits vs. costs, and processes of change) and their relationship to adherence and progression in use of heavier weights in breast cancer survivors (BCS). SAMPLE: Twenty-three BCS with mean age of 54.8 (SD = 7.2) years, mean time since menopause of 5.8 (SD = 5.3) years, and mean time since cancer treatment completion of 4.1 (SD = 3.0) years. METHODS: Exploratory one-group design with multicomponent intervention inclusive of medication, calcium with vitamin D supplement, and home-based SWTE with facilitative strategies by nurses and personal exercise trainers based on the Transtheoretical Model. FINDINGS: BCS doing SWTE for 6 months: (1) maintain a high level of self-efficacy, (2) perceive increasing benefits for 6 months, (3) use cognitive processes more frequently than behavioral ones, (4) were highly adherent to the SWTE, and (5) demonstrate that behavioral processes are positively related to increase in pounds lifted. DISCUSSION/CLINICAL IMPLICATIONS: Larger randomized trials studies are needed to determine the most effective strategies for assuring adherence to and progression of SWTE in this population at risk for osteoporosis.

Testing an intervention for preventing osteoporosis in postmenopausal breast cancer survivors.

PURPOSE: To test a 12-month multicomponent intervention for preventing or treating osteoporosis in 21 postmenopausal women who had completed treatment (except Tamoxifen) for breast cancer, and for whom hormone replacement therapy (HRT) was contraindicated. DESIGN: Pilot intervention study. METHODS: The intervention consisted of home-based strength and weight training exercises, 5 or 10 mg alendronate per day, 1500 mg calcium per day, 400 IU vitamin D per day, education on osteoporosis, and facilitative strategies to promote adherence to the intervention. Outcome measures were: adherence to the intervention, dynamic balance, muscle strength, and bone mineral density (BMD) of the hip, spine, and forearm. FINDINGS AND CONCLUSIONS: Adherence to calcium, vitamin D, and alendronate therapy was above 95%, and adherence to strength training exercises was above 85%. Over the 12 months, the 21 participants had significant improvements in dynamic balance, muscle strength for hip flexion, hip extension, and knee flexion, and BMD of the spine and hip. Participants had a significant decrease in BMD of the forearm. Three of the 21 women who had measurable bone loss at baseline had normal BMD after 12 months of the intervention.