Overview

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)

Status:
Recruiting

Trial end date:
2024-03-01

Target enrollment:

Participant gender:

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

Phase:

Phase 3

Details

Lead Sponsor:

mAbxience S.A

Treatments:

Calcium
Denosumab
Vitamin D