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Clinical Trial Summary

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).


Clinical Trial Description

This was an international, multicenter, randomized, double-blind, parallel-group study with a total duration of up to 83 weeks. The study comprised a screening period of up to 5 weeks to assess a subject's eligibility and two treatment periods: Treatment Period 1 (TP1) from Day 1 to Week 52 and Treatment Period 2 (TP2) from Week 52 to Week 78. Women with postmenopausal osteoporosis (PMO) were randomized on Day 1 in a 1:1 ratio to receive either two 60 mg subcutaneous (s.c.) doses at 26-week intervals of GP2411 (proposed biosimilar denosumab) or EU-Prolia (EU-authorized Prolia®) during TP1. At Week 52, participants in the EU-Prolia group were re-randomized 1:1 to either continue with a third dose of EU-Prolia or switch to GP2411 for TP2. Participants in the GP2411 group continued the treatment with a third dose of GP2411 in TP2. The End of Study was achieved at Week 78. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03974100
Study type Interventional
Source Sandoz
Contact
Status Completed
Phase Phase 3
Start date July 2, 2019
Completion date April 22, 2022

See also
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Active, not recruiting NCT05345691 - Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis Phase 3
Active, not recruiting NCT05338086 - A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study) Phase 3
Completed NCT04757376 - A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis Phase 3
Completed NCT01581320 - Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis Phase 3