NCT05345691

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

A Randomized, Double-Blind, Multicenter, Parallel-Arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Biocon Biologics UK Ltd · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study will consist of 3 study periods: Screening period; Part 1, double-blind active-controlled period; and Part 2, transition period. In the double-blind active-controlled period, eligible Patients will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia®. Prior to dosing At Week 52, patients in Prolia® treatment group will be randomized again in a 1:1 ratio to either continue on Prolia® or be transitioned to Bmab 1000. To maintain the study blinding, the patients in the original Bmab 1000 arm will also go through the re-randomization procedure; however, they will continue to receive Bmab 1000. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously every 6 months. End-of-study visit will be at Week 78 post randomization (Month 18).

Conditions

• Postmenopausal Women With Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	Bmab 1000	60 mg administered as a single SC (subcutaneous) injection once every 6 months.
BIOLOGICAL	Prolia®	60 mg administered as a single SC injection once every 6 months

Timeline

• Start date: 2022-05-24
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2022-04-26
• Last updated: 2025-09-09
• Results posted: 2025-08-19

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study