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NCT02352753 · ClinicalTrials.gov registry record · Phase 3
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT02352753: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT02352753 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02352753, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
Primary Outcome
Lumbar spine BMD was measured by dual-energy X-ray absorptiometry (DXA) adjusted for age, sex, and race/ethnicity. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from Baseline indicated an improvement in lumbar spine BMD.
Interventions
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2015-06-24 |
| Est. Completion | 2022-03-26 |
| Phase | Phase 3 |
Why NCT02352753 stopped before completion
NCT02352753 is an interventional study that assigns participants to a tested intervention. The registered 153 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Denosumab is the first listed.
NCT02352753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02352753 about?
NCT02352753 is a clinical study titled "Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI". This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
What is the current status of trial NCT02352753?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2015-06-24. Estimated completion is 2022-03-26.
What interventions are being tested in trial NCT02352753?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT02352753?
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 NCT02352753's enrollment target sits among peer trials
153 1510th of 2000 higher than 488 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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