NCT05338086

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study was planning to randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a Bone Mineral Density (BMD) consistent with T-score of ≤ -2.5 and ≥ -4 at the lumbar spine or total hip as measured by DXA during the Screening Period. Screening evaluations were to be completed within 28 days prior to randomisation. On Day 1, 528 eligible postmenopausal women with osteoporosis were to be randomised in a 2:1:1 ratio to receive MB09-MB09 (Arm 1), Prolia-MB09 (Arm 2), or Prolia-Prolia (Arm 3) using an Interactive Response Sys-tem (IRT). During the Main Treatment Period, subjects received one subcutaneous injection (60 mg/mL) of study drug on Day 1 and at Month 6. At Month 12, after all efficacy and safety assessments have been performed, the subject were to be enter the Transition/Safety Follow Up Period and were to receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) received MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) received EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) received EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects were to be followed up to Transition Period Month 6. All subjects received daily supplementation of calcium and vitamin D.

Conditions

• Postmenopausal Women With Osteoporosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-16
• Primary completion: 2023-12-14
• Completion: 2024-05-22
• First posted: 2022-04-20
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

64 sites across 8 countries: Bulgaria, Estonia, Georgia, Hungary, Latvia, Mexico, Poland, Serbia