drugset / Trial / NCT06272227
Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group.
Timeline
- Start
- 2024-02-13
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alfacalcidol | Other / unclassified | — | — |
| Background | Denosumab | Monoclonal antibody | — | — |