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

NCT05345691 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 479

Last updated 2025-09-09

Study results available
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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

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

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

Sponsors & Collaborators

  • Biocon Biologics UK Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2024-06-12
Completion
2024-06-12
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345691 on ClinicalTrials.gov