Introduction: Antiresorptive medications increase bone density and decrease vertebral fracture, while high intensity resistance and impact training (HiRIT) increases balance, bone and muscle strength decreasing risk for falls and fractures. Medications are typically prescribed by doctors and exercise by exercise specialists, frequently in isolation.
Objective: Our aim is to determine the influence of antiresorptive osteoporosis medication on the efficacy of HiRIT to improve factors of risk for osteoporotic fracture in postmenopausal women with low bone mass.
Methods and analysis: One hundred and sixty postmenopausal women with low bone mass will be recruited from the community to participate in an eight-month randomised controlled trial. Participants will be on stable doses of antiresorptive bone medication for at least 12 months (n=80) or have not taken bone medications for at least 12 months (n=80). Participants will be block-randomised, stratified by medication intake, to twice-weekly 40-min supervised sessions of either HiRIT or a low intensity exercise program (active control). Primary outcomes include change in lumbar spine and total hip areal bone mineral density (aBMD). Secondary outcomes include whole body, femoral neck and forearm BMD, proximal femur bone geometry and volumetric density, vertebral morphology, body composition, anthropometry, physical function, posture, rate of falls, osteoarthritis symptoms, pelvic floor health, quality of life, physical activity enjoyment, resting blood pressure, safety and compliance. All outcomes will be assessed at baseline and eight months and intention-to-treat and per protocol analyses will be conducted. Repeated measure ANCOVA will be used to determine intervention effects on outcome measures, controlling for initial values, compliance and other variables found to differ between groups at baseline.
Significance: Positive findings from the current study will help to bridge the gap between health care providers in the management of osteoporosis. The study will also examine cost-effectiveness of the different interventions.
Trial registration number: ACTRN12617001511325