At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 527 enrolled
Drug / intervention
GP2411 +1 morebiological
Likely dose
GP2411 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)
In Brief
A Phase 3 clinical trial evaluating GP2411 and EU-Prolia (EU-authorized Prolia®) for Postmenopausal Women With Osteoporosis. Completed, enrolled 527 participants across 42 sites in 6 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Women With Osteoporosis
CountriesBulgaria, Czechia, Japan, Poland, Spain, United States
CollaboratorsHexal AG
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJul 2019
Primary CompletionApr 2022
TodayJul 2026
First PostedJun 4, 2019
Enrollment StartJul 2, 2019
Primary CompletionApr 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.1 years ago
Interventions
GP2411biological
60 mg /mL subcutaneous injection every 6 months
EU-Prolia (EU-authorized Prolia®)biological
60 mg /mL subcutaneous injection every 6 months