drugset / Trial / NCT05884372
Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-08-24
- Primary completion
- 2025-07-16
- Completion
- 2025-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cholecalciferol | Other / unclassified | 800 iu | Oral |
| Subject | Eldecalcitol | Small molecule | 0.75 ug | Oral |
| Comparator | Calcium carbonate | Other / unclassified | 600 mg | Oral |
| Background | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |