Clinical Trials Logo
  1. Home
  2. Postmenopausal Osteoporosis
  3. NCT04934072

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

Postmenopausal Osteoporosis Clinical Trial

Official 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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04934072
Study type Interventional
Source Fresenius Kabi SwissBioSim GmbH
Contact
Status Completed
Phase Phase 3
Start date July 5, 2021
Completion date August 7, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT05087030 - Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis Phase 3
Completed NCT01544894 - Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis Phase 4
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00377819 - Study of Transitioning From Alendronate to Denosumab Phase 3
Completed NCT00239629 - Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial Phase 4
Completed NCT04026256 - Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration Phase 4
Terminated NCT00529373 - A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018) Phase 3
Completed NCT00092014 - A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) Phase 3
Recruiting NCT06079476 - A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. Phase 4
Not yet recruiting NCT04719650 - Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid Phase 4
Recruiting NCT02981732 - CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome N/A
Completed NCT01709110 - VERtebral Fracture Treatment Comparisons in Osteoporotic Women Phase 4
Completed NCT01348243 - Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis Phase 3
Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
Completed NCT00395395 - Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women Phase 1
Completed NCT00247273 - A Study of Monthly Risedronate for Osteoporosis Phase 3
Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
Completed NCT01668589 - Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis N/A
Completed NCT04664959 - A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis Phase 3
Not yet recruiting NCT04719481 - Pravastatin Reduces Acute Phase Response of Zoledronic Acid Phase 4