Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Condition(s) studied
Investigational drug(s) / intervention(s)
Romosozumab: Subcutaneous (SC) injection
Bisphosphonate: Administration determined by investigator according to the local standard of care
Study summary
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
Eligibility
Primary outcome measure(s)
- Number of Clinical Fractures — 12 months
Clinical fractures include clinical vertebral fractures and nonvertebral fractures. - Number of Any Fractures — 12 months
Fractures include new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral fractures. - Change from Baseline in Lumbar Spine BMD Z-score at 12 Months, as assessed by DXA — Baseline and 12 months
Trial sites (65)
| Facility | City | Region | Status |
|---|---|---|---|
| Childrens Hospital of Alabama | Birmingham | Alabama | |
| Phoenix Childrens Hospital | Phoenix | Arizona | |
| University of California, Los Angeles Interventional Clinical Trials | Los Angeles | California | |
| Nemours Hospital for Children | Wilmington | Delaware | |
| Nemours Childrens Hospital | Orlando | Florida | |
| University of South Florida - Carol and Frank Morsani Center for Advanced Health Care | Tampa | Florida | |
| Emory University | Atlanta | Georgia | |
| Indiana University | Indianapolis | Indiana | |
| Kennedy Krieger Institute | Baltimore | Maryland | |
| Boston Childrens Hospital | Boston | Massachusetts | |
| Mayo Clinic Childrens Center | Rochester | Minnesota | |
| Gillette Childrens Hospital and Clinic Saint Paul | Saint Paul | Minnesota | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Marshfield Clinic | Marshfield | Wisconsin | |
| Monash Childrens Hospital | Clayton | Victoria | |
| Perth Childrens Hospital | Nedlands | Western Australia | |
| Kepler Universitaetsklinikum GmbH | Linz | Austria | |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | Belgium | |
| Childrens Hospital of Eastern Ontario | Ottawa | Ontario | |
| The Hospital for Sick Children | Toronto | Ontario | |
| Centre Hospitalier Universitaire Sainte Justine | Montreal | Quebec | |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | |
| The University of Hong Kong-Shenzhen Hospital | Shenzhen | Guangdong | |
| Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | |
| Childrens Hospital of Soochow University | Suzhou | Jiangsu | |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | |
| Shandong Provincial Hospital | Jinan | Shandong | |
| West China Hospital Sichuan University | Chengdu | Sichuan | |
| Shanghai Sixth Peoples Hospital | Shanghai | China | |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin | Bordeaux | France | |
| Centre Hospitalier Regional Universitaire de Lille | Lille | France | |
| Hopital Necker Enfants Malades | Paris | France | |
| Universitaetsklinikum Koeln | Cologne | Germany | |
| Universitaetsklinikum Wuerzburg | Würzburg | Germany | |
| Semmelweis Egyetem | Budapest | Hungary | |
| IRCCS Istituto Giannina Gaslini | Genova | Italy | |
| Centro Ricerche Cliniche Di Verona Societa responsabilita limitata | Verona | Italy | |
| Okayama Saiseikai Outpatient Center Hospital | Okayama | Okayama-ken | |
| Okayama University Hospital | Okayama | Okayama-ken | |
| Osaka Womens and Childrens Hospital | Izumi-shi | Osaka |
+ 25 more sites — see the full list on the official registry below.
More Amgen trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05972551 on ClinicalTrials.gov ↗ ← All trials in the UK