CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 479 enrolled
Drug / intervention
Bmab 1000 +1 morebiological
Likely dose
Bmab 1000 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05345691
NCT05345691Phase 3Completed
CompareCT.gov

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

Biocon Biologics UK Ltd·interventional·Posted Apr 26, 2022·Updated Sep 9, 2025

In Brief

A Phase 3 clinical trial evaluating Bmab 1000 and Prolia® for Postmenopausal Women With Osteoporosis. Completed, enrolled 479 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Women With Osteoporosis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedApr 26, 2022
Enrollment StartMay 24, 2022
Primary CompletionJun 12, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.2 years ago

Interventions

Bmab 1000biological

60 mg administered as a single SC (subcutaneous) injection once every 6 months.

Prolia®biological

60 mg administered as a single SC injection once every 6 months