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NCT03638128 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT03638128: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT03638128 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03638128, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
Primary Outcome
A Serious Adverse Event is defined as any untoward medical occurrence that met at least 1 of the following serious criteria: * Resulted in death (fatal) * Immediately life-threatening * Required in-patient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant disability/incapacity * Was a congenital anomaly/birth defect * Other medically important serious event that may have jeopardized the participant or require medical or surgical intervention to
Interventions
- DRUG Denosumab
- DRUG Alternative osteoporosis medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2022-03-28 |
| Phase | Phase 3 |
Why NCT03638128 stopped before completion
NCT03638128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Denosumab is the first listed.
NCT03638128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03638128 about?
NCT03638128 is a clinical study titled "Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta". To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
What is the current status of trial NCT03638128?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2018-07-26. Estimated completion is 2022-03-28.
What interventions are being tested in trial NCT03638128?
The interventions under investigation include: Denosumab (DRUG), Alternative osteoporosis medications (DRUG).
Who is sponsoring clinical trial NCT03638128?
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 NCT03638128's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 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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