At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
Romosozumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
In Brief
A Phase 1 clinical trial evaluating Romosozumab, Calcium, and 1 other intervention for Osteogenesis Imperfecta. Completed, enrolled 25 participants across 15 sites in 8 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteogenesis Imperfecta
CountriesAustria, Germany, Greece, Hungary, Italy, Spain, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartJan 2021
Primary CompletionMar 2023
TodayJul 2026
First PostedSep 11, 2020
Enrollment StartJan 21, 2021
Primary CompletionMar 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.8 years ago
Interventions
Romosozumabdrug
Participants will receive multiple doses of romosozumab via a SC injection.
Calciumdietary
All participants will receive daily supplements of elemental calcium.
Vitamin Ddietary
All participants will receive daily supplementation with vitamin D.