Phase 3CompletedAge-related condition
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
Randomized, Doubel-blinded, Parallel, Active-controlled Phase III Study, to Evaluate the Efficacy and Safety of CMAB807 Treatment Compared with Prolia® in Chinese Postmenopausal Women with Osteoporosis At High Risk of Fracture.
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd. (Industry)
- Enrolment
- 278 enrolled
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- CMAB807 Injection; Prolia®
- Ages
- adults, older adults
- Registry
- NCT04591275
Full record on ClinicalTrials.gov
From the registry
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
Primary outcomes
- BMD percentage change from baseline at lumbar spine(L1~L4)
History
Last registry update
Primary completion
Started
Registered