At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 558 enrolled
Drug / intervention
MB09 (denosumab biosimilar) +3 moredrug
Likely dose
MB09 (denosumab biosimilar) 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.
A Randomised, Double-blind, Parallel, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) vs. Prolia® (EU-sourced) in Postmenopausal Osteoporosis
In Brief
A Phase 3 clinical trial evaluating MB09 (denosumab biosimilar), EU-Prolia, and 2 other interventions for Postmenopausal Women With Osteoporosis. Completed, enrolled 558 participants across 64 sites in 8 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Women With Osteoporosis
CountriesBulgaria, Estonia, Georgia, Hungary, Latvia, Mexico, Poland, Serbia
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartMar 2022
First PostedApr 2022
Primary CompletionDec 2023
Study CompletionMay 2024
TodayJul 2026
First PostedApr 20, 2022
Enrollment StartMar 16, 2022
Primary CompletionDec 14, 2023
Study CompletionMay 22, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.2 years ago
Interventions
MB09 (denosumab biosimilar)drug
Pre-filled syringe (PFS) 60 mg/mL solution, administered as subcutaneous injection
EU-Proliadrug
PFS 60 mg/mL solution, administered as subcutaneous injection
Elemental Calciumdietary
at least 1000 mg daily
Vitamin Ddietary
at least 400 IU daily