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Clinical Trial Summary

This is 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

Clinical Trial Description

The study will 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 hip as measured by DXA during the Screening Period. Screening evaluations will be completed within 28 days prior to randomisation. On Day 1, 528 eligible postmenopausal women with osteoporosis will be randomised in a 2:1:1 ratio to re-ceive 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 will receive 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 will enter the Transition/Safety Follow Up Period and will receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) will receive MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) will receive EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) will receive EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects will be followed up to Transition Period Month 6. All subjects will receive daily supplementation of calcium and vitamin D. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05338086
Study type Interventional
Source mAbxience Research S.L.
Contact Susana Millan, PhD
Phone +34 917 711 500
Email [email protected]
Status Recruiting
Phase Phase 3
Start date March 31, 2022
Completion date March 2024

See also
  Status Clinical Trial Phase
Completed NCT01249261 - Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover Phase 3
Completed NCT01631214 - Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis Phase 3
Recruiting NCT05345691 - Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis Phase 3
Active, not recruiting NCT04757376 - A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis Phase 3
Completed NCT03974100 - Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis Phase 3
Completed NCT01581320 - Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis Phase 3