At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating ENZ215 and Prolia for Postmenopausal Osteoporosis. Completed, enrolled 504 participants across 48 sites in 7 countries.
Detailed 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
Study Details
Timeline
Interventions
Enrolled women with postmenopausal osteoporosis receive ENZ215 (60mg)
Enrolled women with postmenopausal osteoporosis receive Prolia