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Clinical Trials in the UK / NCT05972551
Active, not recruiting Phase 3

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

NCT05972551 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2024-04-22
Last updated
2026-05-27

Condition(s) studied

Osteogenesis Imperfecta

Investigational drug(s) / intervention(s)

RomosozumabBisphosphonate

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

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. OR * Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. * Ambulatory male and female children and adolescents, age 5 to \<18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population. * Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis). o If familial, also must be autosomal dominant. * Meets at least one of the following: * 3 or more fractures within the previous 2 years, or * 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or * 2 or more prevalent vertebral fractures. Exclusion Criteria: Disease Related * History of an electrophoresis pattern inconsistent with type I, III or IV OI. * History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease. * History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
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

Official registry record

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