drugset / Trial / NCT06272227

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

NCT06272227

Phase 4 Unknown 340 enrolled Yonsei University
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

EvaluationDrugModalityDoseRoute
Subject Alfacalcidol Other / unclassified
Background Denosumab Monoclonal antibody

Indications