The influence of antiresorptive bone medication on the effect of high-intensity resistance and impact training on osteoporotic fracture risk in postmenopausal women with low bone mass: protocol for the MEDEX-OP randomised controlled trial

What is it about?

Osteoporosis and associated fractures constitutes a growing public health problem, causing significant personal, societal and economic burden. The first-line pharmacological therapy of osteoporosis inlcudes prescription of antiresorptive agents (e.g. bisphosphonates, denosumab) as they can increase bone mineral density and reduce risk for vertebral fracture. The most effective non-pharmacological intervention to preserve bone mass and reduce risk of falls and fractures is a program of high intensity progressive resistance and impact training (HiRIT). While antiresorptive medication increases bone density through reduced bone resorption, exercise increases bone formation. Moreover exercise improves muscle strength, mobility and balance and thereby reduces the risk of falling, a major risk factor for fracture. The independent efficacy of drugs and exercise has been confirmed, however, they are typically applied in isolation: medications by doctors and physical activity by exercise specialists. In light of their different mechanisms of action, it is expected that the combination of exercise and antiresorptive drug treatment would be an even more effective strategy to reduce fracture risk than either alone. The aim of the MEDEX-OP trial is therefore to examine the influence of antiresorptive osteoporosis medication on the efficacy of an eight-month, twice-weekly, supervised, HiRIT program on bone mineral density and bone strength at the hip, lumbar spine, forearm and whole body, lean and fat mass, functional performance (muscle strength, mobility, balance), and health related quality of life. Positive findings from the current study will help to bridge the gap between different health care providers in the management of osteoporosis. The study will also examine cost-effectiveness of the different interventions.

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