Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
NCT05884372 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-11-24
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.
Conditions
- Osteoporosis in Postmenopausal Women
Interventions
- DRUG
-
Eldecalcitol
the same as arm descriptions.
- DRUG
-
Native Vitamin D
the same as arm descriptions.
- DRUG
-
the same as arm descriptions.
- DRUG
-
Calcium
the same as arm descriptions.
Sponsors & Collaborators
-
Chugai Pharma China Co., Ltd.
collaborator UNKNOWN -
Xi'an Honghui Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-24
- Primary Completion
- 2025-07-16
- Completion
- 2025-07-16
Countries
- China
Study Locations
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