{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T10:38:08Z","timestamp":1788777488278,"version":"build-2803163510"},"reference-count":30,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2024,8,23]],"date-time":"2024-08-23T00:00:00Z","timestamp":1724371200000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"NORTH Foundation"},{"name":"ANZBMS Clinical Grant Program"},{"name":"Avant Mutual Early Career Research Program","award":["2022\/000291"],"award-info":[{"award-number":["2022\/000291"]}]},{"name":"Department of Endocrinology, Royal North Shore Hospital"},{"name":"Healthy Bones Australia Clinical Grant Program"},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"crossref","award":["2022345"],"award-info":[{"award-number":["2022345"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,8,1]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u2009months. 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12623000867695.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-086708","type":"journal-article","created":{"date-parts":[[2024,8,24]],"date-time":"2024-08-24T04:48:35Z","timestamp":1724474915000},"page":"e086708","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Study protocol for the ROLEX-DUO randomised placebo-controlled trial: ROmosozumab Loaded with EXercise \u2013 DUal effects on bone and muscle in postmenopausal Osteoporosis and Osteopenia"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1242-2476","authenticated-orcid":false,"given":"Shejil","family":"Kumar","sequence":"first","affiliation":[{"name":"Royal North Shore Hospital, Sydney, New South Wales, Australia"},{"name":"The University of Sydney, Sydney, New South Wales, Australia"},{"name":"Westmead Hospital, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1295-6395","authenticated-orcid":false,"given":"Belinda R","family":"Beck","sequence":"additional","affiliation":[{"name":"Griffith University, Gold Coast, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liza","family":"Nery","sequence":"additional","affiliation":[{"name":"Royal North Shore Hospital, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Byth","sequence":"additional","affiliation":[{"name":"Westmead Institute for Medical Research, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Elhindi","sequence":"additional","affiliation":[{"name":"Westmead Institute for Medical Research, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cameron","family":"Wood","sequence":"additional","affiliation":[{"name":"Royal North Shore Hospital, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1914-922X","authenticated-orcid":false,"given":"Oliver K","family":"Fuller","sequence":"additional","affiliation":[{"name":"Monash University, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roderick J","family":"Clifton-Bligh","sequence":"additional","affiliation":[{"name":"Royal North Shore Hospital, Sydney, New South Wales, Australia"},{"name":"The University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian M","family":"Girgis","sequence":"additional","affiliation":[{"name":"The University of Sydney, Sydney, New South Wales, Australia"},{"name":"Westmead Hospital, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,8,24]]},"reference":[{"key":"2025121220391607000_14.8.e086708.1","unstructured":"Watts J-O , Sanders K . 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