Trials / Completed
CompletedNCT04545554
Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romosozumab | Participants will receive multiple doses of romosozumab via a SC injection. |
| DIETARY_SUPPLEMENT | Calcium | All participants will receive daily supplements of elemental calcium. |
| DIETARY_SUPPLEMENT | Vitamin D | All participants will receive daily supplementation with vitamin D. |
Timeline
- Start date
- 2021-01-21
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
- First posted
- 2020-09-11
- Last updated
- 2024-04-15
- Results posted
- 2024-04-15
Locations
15 sites across 8 countries: United States, Austria, Germany, Greece, Hungary, Italy, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04545554. Inclusion in this directory is not an endorsement.