A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

Summary

The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis. The primary goal for the study is 1. To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12 and 2. To compare the AUEC of sCTX levels from baseline to Month 6

Timeline

Start

2022-07-04

Primary completion

2024-07-18

Completion

2024-07-18

Drugs

Indications