Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis

Summary

This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with osteoporosis

Timeline

Start

2022-05-24

Primary completion

2024-06-12

Completion

2024-06-12

Publications

• Eastell R, Orwoll E, Cosman F, Plebanski R, Kumar K, Marwah A, Deodhar SS, Wolff-Holz E, Loganathan S. Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis. JBMR Plus. 2026 Apr 11;10(6):ziag062. doi: 10.1093/jbmrpl/ziag062. eCollection 2026 Jun.

Drugs

Indications