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Clinical trial

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

NCT05338086 is registered in ClinicalTrials.gov with mAbxience Research S.L. as lead sponsor.

NCT NCT05338086
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
mAbxience Research S.L.
Phase
Phase 3
Overall status
Completed
Start date
March 16, 2022
Completion date
May 22, 2024
Enrollment
558 (actual)
Sites
64

Conditions

As the registry lists them; a condition with its own page is linked.

postmenopausal women with osteoporosis