Trials / Completed
CompletedNCT04934072
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 553 (actual)
- Sponsor
- Fresenius Kabi SwissBioSim GmbH · Industry
- Sex
- Female
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FKS518 | subcutaneously by single-use prefilled syringe (PFS) |
| DRUG | US-licensed Prolia (Amgen) | subcutaneously by single-use PFS |
Timeline
- Start date
- 2021-06-16
- Primary completion
- 2023-08-07
- Completion
- 2023-08-07
- First posted
- 2021-06-22
- Last updated
- 2025-02-27
- Results posted
- 2025-02-27
Locations
76 sites across 6 countries: Bulgaria, Czechia, Estonia, Georgia, Hungary, Poland
Source: ClinicalTrials.gov record NCT04934072. Inclusion in this directory is not an endorsement.