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

Abstract

IntroductionAntiresorptive 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.ObjectiveOur primary aim is to determine the effect of an 8-month HiRIT programme with or without osteoporosis medications on bone mineral density (BMD) of the spine and hip in postmenopausal women with low bone mass.Methods and analysisOne hundred and sixty postmenopausal women with low bone mass will be recruited from the community to participate in an 8-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 HiRIT or a low-intensity exercise programme (control). Primary outcomes include change in lumbar spine and total hip areal bone mineral density. 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 8 months and intention-to-treat and per-protocol analyses will be conducted. Repeated measure analysis of covariance 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.Ethics and disseminationThe study has been approved by Griffith University Human Research Ethics Committee (Ref: 2017/739). Results will be reported in peer-reviewed journals and at conferences.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001511325).

A Comparison of Bone-Targeted Exercise With and Without Antiresorptive Bone Medication to Reduce Indices of Fracture Risk in Postmenopausal Women With Low Bone Mass: The MEDEX-OP Randomized Controlled Trial

“…The trial methods have been described in detail in the published protocol. ( 17 ) The MEDEX‐OP trial was an 8‐month, randomized controlled trial conducted in postmenopausal women with low bone mass. Participants who had been on or off stable doses of antiresorptive bone medication treatment for at least 12 months before enrollment were recruited and randomly allocated to HiRIT or BB.…”

“…Volunteers who expressed interest were screened for eligibility criteria as listed in the study protocol. ( 17 ) In brief, participants had to be at least 5 years postmenopause and have low bone mass at the lumbar spine and/or femoral neck based on DXA ( T ‐score ≤ −1.0). Key exclusion criteria were medical conditions or medication intake known to affect bone health other than BPs and Dmab, medical conditions or other reasons that prevent completion of the exercise programs, regular physical activity (≥ 1/week) involving strength, resistance, or high‐impact training activities, or lifestyle choices that could interfere with the trial outcomes (eg, weight loss in the 12 months before enrollment, planned weight loss during the 8‐month study duration, or planned absence of more than 3 weeks from the exercise classes).…”

“…Assessment procedures for all functional performance tests have been described. ( 17 ) Isometric leg extensor strength (LES; TTM Muscular Meter, Tokyo, Japan), ( 26 ) back extensor strength (BES; Lafayette Manual Muscle Testing System, Lafayette, IN, USA) ( 27 ) and dominant and non‐dominant hand grip strength (GS; JAMAR Plus, Patterson Medical, Sammons Preston, Bolingbrook, IL, USA) ( 28 ) were measured by dynamometry. Dynamic balance was measured by the functional reach ( 29 ) and tandem walk test.…”

High-Intensity Exercise and Geometric Indices of Hip Bone Strength in Postmenopausal Women on or off Bone Medication: The MEDEX-OP Randomised Controlled Trial

“…No animal studies were performed in the course of these experiments. The full study protocol has been published [18], and DXA-derived aBMD, functional performance, anthropometric and body composition outcomes as well as incident falls, fractures and adverse events have been reported [11].…”

Current Lack of Evidence for an Effect of Physical Activity Intervention Combined with Pharmacological Treatment on Bone Turnover Biomarkers in People with Osteopenia and Osteoporosis: A Systematic Review

“…Consequently, a focus to expand knowledge on the application of biomarkers to monitor the efficacy of OP multicomponent interventions is of great scientific interest. Moreover, in spite of the fact that drugs and physical activity efficacy has been widely confirmed, they are generally applied separately, not combined [ 41 ].…”