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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
  1. Melanie Fischbacher1,
  2. Benjamin K Weeks1,
  3. Belinda R Beck1,2
  1. 1 Menzies Health Institute Queensland and School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia
  2. 2 The Bone Clinic, Brisbane, Queensland, Australia
  1. Correspondence to Dr Belinda R Beck; b.beck{at}griffith.edu.au

Abstract

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 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 analysis One 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 dissemination The 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 number Australian New Zealand Clinical Trials Registry (ACTRN12617001511325).

  • bone mineral density
  • exercise
  • fracture prevention
  • osteoporosis
  • Pilates
  • resistance training

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors Conception and design of the study; manuscript preparation and editing the final paper for submission; preparation of information sheets, consent forms and case report forms: MF, BWK and BRB. Participant recruitment, data collection and participant training: MF. Principle investigator: BRB.

  • Funding This research is an PhD project supported by a Griffith University Postgraduate International Research Scholarship, a Griffith University Postgraduate Research Scholarship and Griffith University Higher Degree Research student funds. A small (AU$2000) grant was awarded to MF from Sport Medicine Australia (SMA) Research foundation. No other major funding has been received from public, commercial or not-for-profit agencies.

  • Competing interests BRB is a codirector and shareholder of the The Bone Clinic.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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