AI Article Synopsis

  • The ROLEX-DUO study is a randomized controlled trial aimed at understanding if high-intensity resistance and impact exercise combined with romosozumab can improve bone density and muscle outcomes in postmenopausal women with osteoporosis/osteopenia.
  • The trial involves 102 participants who will be divided into three groups: one receiving romosozumab with supervised high-intensity exercise, another receiving romosozumab with low-intensity exercise, and a third group getting a placebo with low-intensity exercise.
  • Key outcomes to be measured include changes in lumbar spine bone mineral density and performance on a sit-to-stand test, along with various secondary health indicators related to bone health and quality of life over an 8-month period

Article Abstract

Introduction: Novel strategies are needed to address the rising burden of osteoporosis and fragility fractures. High-intensity resistance and impact (HiRIT) exercise has shown benefit in improving bone density in postmenopausal women with osteoporosis/osteopenia. Whether HiRIT can enhance the therapeutic effects of osteoporosis pharmacotherapy has not been established. ROLEX-DUO is a randomised controlled trial designed to assess the efficacy of romosozumab on various bone and muscle outcomes in combination with different exercise interventions in women with postmenopausal osteoporosis/osteopenia.

Methods And Analysis: ROLEX-DUO is an 8-month randomised placebo-controlled trial conducted at two tertiary referral centres for patients with osteoporosis/osteopenia in Sydney, New South Wales, Australia. The study is implementing the combination of romosozumab or placebo with different forms of exercise in postmenopausal women with osteoporosis/osteopenia without recent fragility fracture (n=102). Eligible women will be randomised 1:1:1 into one of three groups: (1) romosozumab with supervised HiRIT, (2) romosozumab with unsupervised low-intensity exercise or (3) placebo with unsupervised low-intensity exercise. Co-primary outcomes are the mean percentage change in lumbar spine bone mineral density (BMD), and mean change in five times sit-to-stand test performance (seconds) at 8 months. Secondary/exploratory outcomes include BMD changes at the femoral neck, total hip and distal radius, three-dimensional dual-energy X-ray absorptiometry (DXA) hip outcomes, DXA-derived lean and fat mass, serum markers of bone turnover (procollagen type 1 peptide, C-telopeptide of type 1 collagen) and bone biomarkers (dickkopf-1), serum extracellular vesicle analyses, 36-Item Short Form Survey (SF-36) quality-of-life scores, Menopause-Specific Quality Of Life (MENQOL) Questionnaire menopause symptom burden scores, number of falls and fractures. Mixed-effects models will be performed to compare longitudinal outcome results between groups using intention-to-treat analysis.

Ethics And Dissemination: The trial was approved by the Northern Sydney Local Health District Human Research Ethics Committee (2022/ETH01794, protocol V.8, dated 03 July 2024). Participants will provide written informed consent prior to inclusion. Findings will be disseminated via peer-reviewed journals, scientific conferences and summary reports to funding bodies.

Trial Registration Number: ACTRN12623000867695.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344515PMC
http://dx.doi.org/10.1136/bmjopen-2024-086708DOI Listing

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