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Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

NCT03974100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2023-03-08

Study results available
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Summary

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

BIOLOGICAL

GP2411

60 mg /mL subcutaneous injection every 6 months

BIOLOGICAL

EU-Prolia (EU-authorized Prolia®)

60 mg /mL subcutaneous injection every 6 months

Sponsors & Collaborators

  • Hexal AG

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2022-04-22
Completion
2022-04-22
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Japan
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT03974100 on ClinicalTrials.gov