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A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.

NCT05338086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2025-03-21

Study results available
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Summary

This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

DRUG

MB09 (denosumab biosimilar)

Pre-filled syringe (PFS) 60 mg/mL solution, administered as subcutaneous injection

DRUG

EU-Prolia

PFS 60 mg/mL solution, administered as subcutaneous injection

DIETARY_SUPPLEMENT

Elemental Calcium

at least 1000 mg daily

DIETARY_SUPPLEMENT

Vitamin D

at least 400 IU daily

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2023-12-14
Completion
2024-05-22

Countries

  • Bulgaria
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Mexico
  • Poland
  • Serbia

Study Locations

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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 NCT05338086 on ClinicalTrials.gov