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

NCT05345691 | Completed Phase 3 Results FDA Drug

• 1 other identifier: B1000-PMO-03-G-02
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Lumbar Spine BMD (Bone Mineral Density)

  To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in lumbar spine BMD

  Baseline and Week 52

Secondary Outcomes (17)

• AUEC (Area Under the Effect Curve) of the Bone Resorption Marker sCTX (Serum C-terminal Telopeptide of Type 1 Collagen)

  Baseline to Week 26

• Percentage Change in Lumbar Spine BMD

  Baseline and Week 26

• Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)

  Baseline upto week 26

• Serum Concentrations of P1NP (Procollagen Type 1 N-terminal Propeptide)

  Baseline up to Week 52

• Incidence of TEAEs (Treatment-emergent Adverse Events) up to 6 Months After the Second Dose

  Baseline up to Week 78

Study Arms (2)

Bmab 1000

EXPERIMENTAL

Biological: Bmab 1000

Prolia®:

ACTIVE COMPARATOR

Biological: Prolia®

Interventions

Bmab 1000 BIOLOGICAL

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

Bmab 1000

Prolia® BIOLOGICAL

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

Prolia®:

Eligibility Criteria

• Age: 55 Years - 80 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women, aged ≥55 and \<80 years at screening. Postmenopausal is defined as 12 months of spontaneous amenorrhea with serum FSH (follicle-stimulating hormone) levels ≥40 mIU/mL at screening or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
• Evidence of osteoporosis as assessed by lumbar spine (L1-L4) absolute BMD corresponding to a T-score classification ≤-2.5 and ≥-4.0.
• At least 3 vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA at screening.
• Patients with body weight ≥50 to \<90 kg at screening.

You may not qualify if:

• Patients with T-score of \<-4.0 at the lumbar spine, total hip, or femoral neck.
• Known history of previous exposure to denosumab (Prolia®, Xgeva®, or any biosimilar denosumab).
• For prior or ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements) following points to be considered for the washout periods prior to the screening visit:
• a. Oral bisphosphonate i. Ineligible if used for 3 or more years cumulatively ii. If used for \<3 years, a gap of at least 1 year since the last dose is required at the screening visit b. Dose received any time
• Systemic glucocorticosteroids
• Patients with ongoing serious infections
• Evidence of any of the following per the patient's history, DXA, or X-ray review and/or current disease:
• Patient in bed rest for 2 or more weeks during the last 3 months prior to screening
• Current hyperthyroidism or hypothyroidism
• History and/or current hyperparathyroidism or hypoparathyroidism
• Current hypocalcemia or hypercalcemia based on albumin-adjusted serum calcium
• Any bone disease including bone metastasis or metabolic disease (except for osteoporosis), eg, osteomalacia or osteogenesis imperfecta, rheumatoid arthritis, Paget's disease, ALP (alkaline phosphatase) elevation (at investigator's discretion), Cushing's disease, clinically significant hyperprolactinemia (at investigator's discretion), fibrous dysplasia, malabsorption syndrome which may interfere with the interpretation of the results
• History and/or presence of one severe or 3 or more moderate vertebral fractures
• History and/or presence of hip fracture or bilateral hip replacement
• Presence of an active healing fracture according to assessment of investigator

Sponsors & Collaborators

• Biocon Biologics UK Ltd: lead

Study Sites (1)

PPD Global Ltd, Granta Park, Great Abington,

Cambridge, UK, CB21 6GQ, United Kingdom

Location

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sarika S Deodhar
• Organization: Biocon Biologics Limited

Sarika.Deodhar@biocon.com

0802808

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (Patient, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 26, 2022
• Study Start: May 24, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: September 9, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)