drugset / Trial / NCT05087030
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.
Timeline
- Start
- 2021-09-21
- Primary completion
- 2023-10-02
- Completion
- 2023-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Denosumab | Monoclonal antibody | — | Subcutaneous |
| Subject | RGB-14-P | Unknown | — | Subcutaneous |