Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272227
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-14
Brief Title:
Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients Double-blinded Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None