At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 553 enrolled
Drug / intervention
FKS518 +1 moredrug
Likely dose
Not stated in 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 Double-blind, Randomized, Multicenter, Multiple-dose, 2-arm, Parallel-group Study to Evaluate Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 - Proposed Biosimilar to Denosumab With Prolia® in Postmenopausal Women With Osteoporosis (LUMIADE-3 Study)
In Brief
A Phase 3 clinical trial evaluating FKS518 and US-licensed Prolia (Amgen) for Postmenopausal Osteoporosis. Completed, enrolled 553 participants across 76 sites in 6 countries.
Detailed Summary
The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesBulgaria, Czechia, Estonia, Georgia, Hungary, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartJun 2021
First PostedJun 2021
Primary CompletionAug 2023
TodayJul 2026
First PostedJun 22, 2021
Enrollment StartJun 16, 2021
Primary CompletionAug 7, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.0 years ago
Interventions
FKS518drug
subcutaneously by single-use prefilled syringe (PFS)
US-licensed Prolia (Amgen)drug
subcutaneously by single-use PFS