Background Determining anatomic sites and circumstances under which a fracture may be a consequence of osteoporosis is a topic of ongoing debate and controversy that is important to both clinicians and researchers. Methods We conducted a systematic literature review and generated an evidence report on fracture risk based on specific anatomic bone sites as well as fracture diagnosis codes. Using the RAND/UCLA appropriateness process, we convened a multi-disciplinary panel of 11 experts who rated fractures according to their likelihood of being due to osteoporosis based on the evidence report. Fracture sites (as determined by ICD-CM codes) were stratified by four clinical risk factor categories based on age, sex, race/ethnicity (African- American and Caucasian) and presence or absence of trauma. Results Consistent with current clinical experience, the fractures rated most likely due to osteoporosis were the femoral neck, pathologic fractures of the vertebrae, and lumbar and thoracic vertebral fractures. The fractures rated least likely due to osteoporosis were open proximal humerus fractures, skull, and facial bones. The expert panel rated open fractures of the arm (except proximal humerus) and fractures of the tibia/fibula, patella, ribs, and sacrum as being highly likely due to osteoporosis in older Caucasian women but a lower likelihood in younger African American men. Conclusion Osteoporosis attribution scores for all fracture sites were determined by a multidisciplinary expert panel to provide an evidence-based continuum of the likelihood of a fracture being associated with osteoporosis.

IMPORTANCEIt is unclear how effective intermittent fasting is for losing weight and body fat, and the effects may depend on the timing of the eating window. This randomized trial compared time-restricted eating (TRE) with eating over a period of 12 or more hours while matching weight-loss counseling across groups.OBJECTIVE To determine whether practicing TRE by eating early in the day (eTRE) is more effective for weight loss, fat loss, and cardiometabolic health than eating over a period of 12 or more hours. DESIGN, SETTING, AND PARTICIPANTSThe study was a 14-week, parallel-arm, randomized clinical trial conducted between August 2018 and April 2020. Participants were adults aged 25 to 75 years with obesity and who received weight-loss treatment through the Weight Loss Medicine Clinic at the University of Alabama at Birmingham Hospital.INTERVENTIONS All participants received weight-loss treatment (energy restriction [ER]) and were randomized to eTRE plus ER (8-hour eating window from 7:00 to 15:00) or control eating (CON) plus ER (Ն12-hour window). MAIN OUTCOMES AND MEASURESThe co-primary outcomes were weight loss and fat loss. Secondary outcomes included blood pressure, heart rate, glucose levels, insulin levels, and plasma lipid levels.RESULTS Ninety participants were enrolled (mean [SD] body mass index, 39.6 [6.7]; age, 43 [11] years; 72 [80%] female). The eTRE+ER group adhered 6.0 (0.8) days per week. The eTRE+ER intervention was more effective for losing weight (−2.3 kg; 95% CI, −3.7 to −0.9 kg; P = .002) but did not affect body fat (−1.4 kg; 95% CI, −2.9 to 0.2 kg; P = .09) or the ratio of fat loss to weight loss (−4.2%; 95% CI, −14.9 to 6.5%; P = .43). The effects of eTRE+ER were equivalent to reducing calorie intake by an additional 214 kcal/d. The eTRE+ER intervention also improved diastolic blood pressure (−4 mm Hg; 95% CI, −8 to 0 mm Hg; P = .04) and mood disturbances, including fatigue-inertia, vigor-activity, and depression-dejection. All other cardiometabolic risk factors, food intake, physical activity, and sleep outcomes were similar between groups. In a secondary analysis of 59 completers, eTRE+ER was also more effective for losing body fat and trunk fat than CON+ER. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, eTRE was more effective for losing weight and improving diastolic blood pressure and mood than eating over a window of 12 or more hours at 14 weeks.TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03459703

ObjectiveMethods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial.MethodsNine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands.ResultsThe nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08].ConclusionsAlthough, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials.

Osteoporosis is a leading health problem worldwide due to the morbidity and mortality associated with fractures. However, a large number of fractures occur in persons without osteoporosis, when defined by bone mineral density alone. Numerous studies have shown that the risk of subsequent fracture is increased following fractures at most sites, and the increased risk is not limited to prior hip and vertebral fractures only. In addition, the amount of trauma present at the time of a fracture event appears to have limited impact on future fracture risk. Thus, even fractures that occur in the presence of high trauma should be recognized as evidence of possible bone fragility. Further methods to better identify persons at risk of future fracture are needed, such as through evaluation of other indicators of bone strength or recognition of modifiable, non-bone factors. Any initial fracture event is important for patients and caregivers to recognize as an implication for future fracture risk.

Osteoporosis treatment rates are declining, even among those with past fractures. Novel, low-cost approaches are needed to improve osteoporosis care. We conducted a parallel group, controlled, randomized clinical trial evaluating a behavioral intervention for improving osteoporosis medication use. A total of 2,684 women with self-reported fracture history after age 45 not using osteoporosis therapy from U.S. Global Longitudinal study of Osteoporosis in Women (GLOW) sites were randomized 1:1 to receive a multi-modal, tailored, direct-to-patient, video intervention vs. usual care. The primary study outcome was self-report of osteoporosis medication use at 6-months. Other outcomes included calcium and vitamin D supplementation, bone mineral density (BMD) testing, readiness for behavioral change, and barriers to treatment. In intent-to-treat analyses there were no significant differences between groups (intervention vs control) in osteoporosis medication use (11.7% vs 11.4%, p=0.8), calcium supplementation (31.8% vs 32.6%, p=0.7), vitamin D intake (41.3% vs. 41.9%, p=0.8) or BMD testing (61.8% vs 57.1%, p=0.2). In the intervention group, fewer women were in the pre-contemplative stage of behavior change, more women reported seeing their primary care provider, had concerns regarding osteonecrosis of the jaw, and difficulty in taking/remembering to take osteoporosis medications. We found differences in BMD testing among the subgroup of women with no prior osteoporosis treatment, those who provided contact information, and those with no past BMD testing. In per protocol analyses, women with appreciable exposure to the online intervention (N=257) were more likely to start non-bisphosphonates (OR=2.70 [1.26, 5.79]) compared to usual care group. While our intervention did not increase the use of osteoporosis therapy at 6-months, it increased non-bisphosphonate medication use and BMD testing in select subgroups, shifted participant’s readiness for behavior change, and altered perceptions of barriers to osteoporosis treatment. Achieving changes in osteoporosis care using patient activation approaches alone is challenging. Trial Registration clinicaltrials.gov identifier: NCT01907269