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NCT04545554 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT04545554 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 25 participants.
The verdict
NCT04545554, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).
Interventions
- DRUG Romosozumab
- DIETARY_SUPPLEMENT Vitamin D
- DIETARY_SUPPLEMENT Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545554
The ClinicalTrials.gov registry entry for NCT04545554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Romosozumab is the first listed.
NCT04545554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04545554 about?
NCT04545554 is a clinical study titled "Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta". The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).
What is the current status of trial NCT04545554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-01-21. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT04545554?
The interventions under investigation include: Romosozumab (DRUG), Vitamin D (DIETARY_SUPPLEMENT), Calcium (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04545554?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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