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NCT03974100 · ClinicalTrials.gov registry record · Phase 3
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
A Phase 3 study, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 527
- Enrollment target
NCT03974100 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 527 participants.
The verdict
NCT03974100, a Phase 3 study, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 527 participants
- Enrollment target
Study 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).
Interventions
- BIOLOGICAL GP2411
- BIOLOGICAL EU-Prolia (EU-authorized Prolia®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2022-04-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03974100
The ClinicalTrials.gov registry entry for NCT03974100 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 527 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GP2411 is the first listed.
NCT03974100 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03974100 about?
NCT03974100 is a clinical study titled "Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis". 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).
What is the current status of trial NCT03974100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 527 participants. The study started on 2019-07-02. Estimated completion is 2022-04-22.
What interventions are being tested in trial NCT03974100?
The interventions under investigation include: GP2411 (BIOLOGICAL), EU-Prolia (EU-authorized Prolia®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03974100?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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