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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: Completed Phase 3 study, sponsored by Sandoz.
NCT03974100 is a Phase 3 study that has completed, run by Sandoz. The registered enrollment target is 527 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Bone density measurements were performed by dual energy X-ray absorptiometry (DXA). Lumbar spine scan included L1 through L4 vertebrae. All DXA scans were submitted to a central imaging vendor for analysis. A mixed effect model for repeated measurements (MMRM) was fitted to the changes from baseline in LS-BMD for all post-baseline time points up to Week 52. Values at Week 52 were estimated from the model and are presented in the table.
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 |
What the finished NCT03974100 record still lists
NCT03974100 is an interventional study that assigns participants to a tested intervention. The registered 527 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which GP2411 is the first listed.
NCT03974100 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03974100's enrollment target sits among peer trials
527 715th of 2000 higher than 1,286 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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