A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis

Details

Instance of

clinical trial

Start time

June 2021

End time

20 March 2023

Main subject

denosumab, osteoporosis

clinical trial phase

phase III clinical trial

maximum age

85

minimum age

55

number of participants

526

research intervention

denosumab

research subject recruitment status

not yet recruiting

study type

interventional study

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)