Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
NCT ID: NCT05972551
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
106 participants
INTERVENTIONAL
2024-04-22
2027-08-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Romosozumab
Participants will receive romosozumab once a month (QM) for 12 months.
Romosozumab
Subcutaneous (SC) injection
Standard of Care Bisphosphonate
Participants will receive bisphosphonates per local standard of care treatment regimens, as determined by the investigator for 12 months.
Bisphosphonate
Administration determined by investigator according to the local standard of care
Interventions
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Romosozumab
Subcutaneous (SC) injection
Bisphosphonate
Administration determined by investigator according to the local standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
5 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Childrens Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Nemours Hospital for Children
Wilmington, Delaware, United States
Nemours Childrens Hospital
Orlando, Florida, United States
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Mayo Clinic Childrens Center
Rochester, Minnesota, United States
Gillette Childrens Hospital and Clinic Saint Paul
Saint Paul, Minnesota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Monash Childrens Hospital
Clayton, Victoria, Australia
Perth Childrens Hospital
Nedlands, Western Australia, Australia
Kepler Universitaetsklinikum GmbH
Linz, , Austria
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, , Belgium
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China
Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Shanghai Sixth Peoples Hospital
Shanghai, , China
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, , France
Hopital Necker Enfants Malades
Paris, , France
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka Womens and Childrens Hospital
Izumi-shi, Osaka, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Centermed Krakow Sp zoo
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds
Lodz, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia
Tychy, , Poland
Narodny ustav detskych chorob
Bratislava, , Slovakia
Hospital de Cruces
Barakaldo, Basque Country, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Sant Joan de Deu
Esplugues de Llorbregat, Catalonia, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario Infantil Niño Jesus
Madrid, , Spain
Universitaets-Kinderspital beider Basel
Basel, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, , Turkey (Türkiye)
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon, , Turkey (Türkiye)
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Royal Manchester Childrens Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-503294-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20200105
Identifier Type: -
Identifier Source: org_study_id