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NCT03164928 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT03164928: Completed Phase 3 study, sponsored by Amgen.
NCT03164928 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03164928, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).
Primary Outcome
Lumbar spine BMD was assessed by DXA and analyzed by analysis of covariance (ANCOVA) including treatment (denosumab vs placebo), baseline age, and baseline BMD z-score. DXA results were converted to z-scores, indicating number of standard deviations from the reference population's mean, with 0 denoting the mean. Positive changes from baseline signify lumbar spine BMD improvement.
Interventions
- OTHER Placebo
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2023-12-20 |
| Phase | Phase 3 |
What the finished NCT03164928 record still lists
NCT03164928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03164928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03164928 about?
NCT03164928 is a clinical study titled "Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis". To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).
What is the current status of trial NCT03164928?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2018-05-07. Estimated completion is 2023-12-20.
What interventions are being tested in trial NCT03164928?
The interventions under investigation include: Placebo (OTHER), Denosumab (DRUG).
Who is sponsoring clinical trial NCT03164928?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03164928's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 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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