Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Primary objective: To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density. Secondary objective: To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5.
• 2.Voluntarily participate in this study and sign the informed consent.
Locations
Other Locations
China
Zeng,Yuhong
RECRUITING
Xi'an
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2025-06
Participants
Target number of participants: 100
Treatments
Experimental: Denosumab+Eldecalcitol
Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.
Active_comparator: Denosumab+Native Vitamin D+Calcium
Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months.
Related Therapeutic Areas
Sponsors
Leads: Xi'an Honghui Hospital
Collaborators: Chugai Pharma China Co., Ltd.