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
Phase: PHASE3
Conditions: Postmenopausal Women With Osteoporosis
Sponsor: mAbxience Research S.L.

Protocol Title: 
A randomised, double-blind, parallel, 
multicentre, multinational study to compare 
the efficacy, pharmacokinetics, 
pharmacodynamics, safety and 
immunogenicity of MB09 (proposed 
denosumab biosimilar) versus Prolia® (EU-
sourced) in postmenopausal women with 
osteoporosis (SIMBA Study) 
NCT Number: 
NCT05338086 
Protocol version 
date: 
Version 2.0, 07 November 2022