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

NCT04934072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2025-02-27

Study results available
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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

  • Postmenopausal Osteoporosis

Interventions

DRUG

FKS518

subcutaneously by single-use prefilled syringe (PFS)

DRUG

US-licensed Prolia (Amgen)

subcutaneously by single-use PFS

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2023-08-07
Completion
2023-08-07

Countries

  • Bulgaria
  • Czechia
  • Estonia
  • Georgia
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934072 on ClinicalTrials.gov