Clinical trial
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)
NCT04934072 is registered in ClinicalTrials.gov with Fresenius Kabi SwissBioSim GmbH as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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)
- Lead sponsor
- Fresenius Kabi SwissBioSim GmbH
- Phase
- Phase 3
- Overall status
- Completed
- Start date
- June 16, 2021
- Completion date
- August 7, 2023
- Enrollment
- 553 (actual)
- Sites
- 76
Conditions
As the registry lists them; a condition with its own page is linked.
postmenopausal osteoporosis