The effect of low-intensity whole-body vibration with or without high-intensity resistance and impact training on risk factors for proximal femur fragility fracture in postmenopausal women with low bone mass: study protocol for the VIBMOR randomized controlled trial

Background The prevailing medical opinion is that medication is the primary (some might argue, only) effective intervention for osteoporosis. It is nevertheless recognized that osteoporosis medications are not universally effective, tolerated, or acceptable to patients. Mechanical loading, such as vibration and exercise, can also be osteogenic but the degree, relative efficacy, and combined effect is unknown. The purpose of the VIBMOR trial is to determine the efficacy of low-intensity whole-body vibration (LIV), bone-targeted, high-intensity resistance and impact training (HiRIT), or the combination of LIV and HiRIT on risk factors for hip fracture in postmenopausal women with osteopenia and osteoporosis. Methods Postmenopausal women with low areal bone mineral density (aBMD) at the proximal femur and/or lumbar spine, with or without a history of fragility fracture, and either on or off osteoporosis medications will be recruited. Eligible participants will be randomly allocated to one of four trial arms for 9 months: LIV, HiRIT, LIV + HiRIT, or control (low-intensity, home-based exercise). Allocation will be block-randomized, stratified by use of osteoporosis medications. Testing will be performed at three time points: baseline (T0), post-intervention (T1; 9 months), and 1 year thereafter (T2; 21 months) to examine detraining effects. The primary outcome measure will be total hip aBMD determined by dual-energy X-ray absorptiometry (DXA). Secondary outcomes will include aBMD at other regions, anthropometrics, and other indices of bone strength, body composition, physical function, kyphosis, muscle strength and power, balance, falls, and intervention compliance. Exploratory outcomes include bone turnover markers, pelvic floor health, quality of life, physical activity enjoyment, adverse events, and fracture. An economic evaluation will also be conducted. Discussion No previous studies have compared the effect of LIV alone or in combination with bone-targeted HiRIT (with or without osteoporosis medications) on risk factors for hip fracture in postmenopausal women with low bone mass. Should either, both, or combined mechanical interventions be safe and efficacious, alternative therapeutic avenues will be available to individuals at elevated risk of fragility fracture who are unresponsive to or unwilling or unable to take osteoporosis medications. Trial registration Australian New Zealand Clinical Trials Registry (www. anzctr.org.au) (Trial number ANZCTR12615000848505, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 368962); date of registration 14/08/2015 (prospectively registered). Universal Trial Number: U1111-1172-3652.

Fragility fractures and prescriptions of medications for osteoporosis in patients with polymyalgia rheumatica: results from the PMR Cohort Study

Objectives Polymyalgia rheumatica (PMR) is a common indication for long-term glucocorticoid treatment leading to an increased risk of osteoporosis and fragility fractures. Guidelines recommend calcium and vitamin D for all patients, as well as anti-resorptive agents for high-risk patients. This study aimed to investigate falls and fragility fracture history and use of medications for osteoporosis in a PMR cohort. Methods 652 people with incident PMR responded to a postal survey. Self-reported data on falls, fragility fracture history and medication were collected at baseline. Follow up data on fragility fractures (hip, wrist, spine) and falls were collected at 12 and 24 months. Logistic regression was used to assess the association between baseline characteristics and fractures. Results Fewer than 50% of respondents received osteoporosis treatments, including supplements. 112 (17.2%) participants reported a fragility fracture at baseline, 72 participants reported a fracture at 12 months, whilst 62 reported a fracture at 24-months. Baseline history of falls was most strongly associated with fracture at 12 (OR 2.35; 95% CI 1.35, 4.12) and 24 months (1.91; 1.05, 3.49) when unadjusted for previous fractures. Conclusions Fracture reporting is common in people with PMR. To improve fracture prevention, falls assessment and interventions need to be considered. History of falls could help inform prescribing decisions around medications for osteoporosis. Future research should consider both pharmacological and non-pharmacological approaches to reducing fracture risk.