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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
340
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).
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).
denosumab
Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital
Seoul, South Korea
Improvement in SPPB score of 0.5 or more compared to the control group
Our study aim is to demonstrate the improvement in SPPB(Short physical performace battery) score of 0.5 or more in the alfacalcidol group compared to the placebo group.
Time frame: one year
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