NCT06272227

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients; Double-blinded Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is a double-blind, randomized phase 4 trial to evaluate whether alfacalcidol co-administration improves muscle function compared to the placebo group in functional sarcopenia women over 65 years of age who are taking denosumab for osteoporosis. This trial consists of four trial periods (Screening Visit 1, Baseline Visit 2, Visit 3 (26 weeks), and Visit 4 (52 weeks).

Conditions

• Sarcopenia

Interventions

Type	Name	Description
DRUG	alfacalcidol	Subjects assigned to arm 1 take two doses of alfacalcidol once a day for a total of 52 weeks from the day after baseline visit 2 to the day before the end of the test (visit 4).
DRUG	placebo	Subjects assigned to arm 2 take two doses of placebo once a day for a total of 52 weeks from the day after baseline visit 2 to the day before the end of the test (visit 4).
DRUG	Denosumab	denosumab

Timeline

• Start date: 2024-02-13
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-02-22
• Last updated: 2024-02-22

Locations

1 site across 1 country: South Korea