Kumar S, Beck BR, Nery L, Byth K, Elhindi J, Wood C, Fuller OK, Clifton-Bligh RJ, Girgis CM. Study protocol for the ROLEX-DUO randomised placebo-controlled trial: ROmosozumab Loaded with EXercise - DUal effects on bone and muscle in postmenopausal Osteoporosis and Osteopenia. BMJ Open. 2024 Aug 24;14(8):e086708. doi: 10.1136/bmjopen-2024-086708. PMID: 39181562; PMCID: PMC11344515.
Study has 3 arms
- romosozumab with supervised High Intensity Resistance and Impact Training (HiRIT)
- romosozumab with unsupervised low-intensity exercise
- placebo with unsupervised low-intensity exercise
Co-primary outcomes
- 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
- 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)
- 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.
Status
- Enrollment: began April 2024
- Enrollment completed: Dec 2025
- Study completion: expected Sept 2026
- Final results: expected end of 2026