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Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

NCT06272227 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06272227 on ClinicalTrials.gov