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

  • STATUS
    Not Recruiting
  • End date
    Mar 20, 2023
  • participants needed
    526
  • sponsor
    Fresenius Kabi SwissBioSim GmbH
Updated on 14 September 2022
body mass index
hysterectomy
x-rays
denosumab
bone mineral density
prolia
x-ray absorptiometry
postmenopausal osteoporosis

Summary

The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).

Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks.

At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks.

Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period.

For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.

Details
Condition Osteoporosis, Post-Menopausal Osteoporosis, Postmenopausal osteoporosis, Post-Menopausal Osteopenia
Treatment US-licensed Prolia, FKS518
Clinical Study IdentifierNCT04934072
SponsorFresenius Kabi SwissBioSim GmbH
Last Modified on14 September 2022

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