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Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Sponsor: Amgen
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.
Official title: A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2024-04-22
Completion Date
2027-08-25
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Romosozumab
Subcutaneous (SC) injection
Bisphosphonate
Administration determined by investigator according to the local standard of care
Locations (65)
Childrens Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
University of California, Los Angeles Interventional Clinical Trials
Los Angeles, California, 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
Marshfield Clinic
Marshfield, Wisconsin, 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
Childrens Hospital of Soochow University
Suzhou, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Hospital
Jinan, Shandong, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
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, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka Womens and Childrens Hospital
Izumi-shi, Osaka, Japan
Tokyo Metropolitan Children's Medical Center
Fuchu-shi, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Tottori University Hospital
Yonago-shi, Tottori, 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
Centrum Medyczne Medyk Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Rzeszów, Poland
Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia
Tychy, Poland
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia
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 Llobregat, 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
Sheffield Childrens Hospital
Sheffield, United Kingdom