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

PHASE3RecruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

April 22, 2024

Primary Completion Date

June 1, 2027

Study Completion Date

August 25, 2027

Conditions
Osteogenesis Imperfecta
Interventions
DRUG

Romosozumab

Subcutaneous (SC) injection

DRUG

Bisphosphonate

Administration determined by investigator according to the local standard of care

Trial Locations (51)

1011

RECRUITING

Centre Hospitalier Universitaire Vaudois, Lausanne

1094

RECRUITING

Semmelweis Egyetem, Budapest

3000

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3168

RECRUITING

Monash Childrens Hospital, Clayton

4020

RECRUITING

Kepler Universitaetsklinikum GmbH, Linz

4031

RECRUITING

Universitaets-Kinderspital beider Basel, Basel

6909

RECRUITING

Perth Childrens Hospital, Nedlands

19803

RECRUITING

Nemours Hospital for Children, Wilmington

21287

RECRUITING

Kennedy Krieger Institute, Baltimore

28009

RECRUITING

Hospital Universitario Infantil Niño Jesus, Madrid

28905

RECRUITING

Hospital Universitario de Getafe, Getafe

30322

RECRUITING

Emory University, Atlanta

33076

RECRUITING

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin, Bordeaux

33606

RECRUITING

University of South Florida - Carol and Frank Morsani Center for Advanced Health Care, Tampa

34890

RECRUITING

Marmara Universitesi Tip Fakultesi Hastanesi, Istanbul

35100

RECRUITING

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

35233

RECRUITING

Childrens Hospital of Alabama, Birmingham

46026

RECRUITING

Hospital Universitari i Politecnic La Fe, Valencia

46202

RECRUITING

Indiana University, Indianapolis

48903

RECRUITING

Hospital de Cruces, Barakaldo

50937

RECRUITING

Universitaetsklinikum Koeln, Cologne

55101

RECRUITING

Gillette Childrens Hospital and Clinic Saint Paul, Saint Paul

55905

TERMINATED

Mayo Clinic Childrens Center, Rochester

61080

RECRUITING

Karadeniz Teknik Universitesi Hastanesi, Trabzon

75743

RECRUITING

Hopital Necker Enfants Malades, Paris

85016

RECRUITING

Phoenix Childrens Hospital, Phoenix

97074

RECRUITING

Universitaetsklinikum Wuerzburg, Würzburg

100730

RECRUITING

Peking Union Medical College Hospital, Beijing

130021

RECRUITING

The First Bethune Hospital of Jilin University, Changchun

200233

RECRUITING

Shanghai Sixth Peoples Hospital, Shanghai

430030

RECRUITING

Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology, Wuhan

518053

RECRUITING

The University of Hong Kong-Shenzhen Hospital, Shenzhen

610044

RECRUITING

West China Hospital of Sichuan University, Chengdu

02115

RECRUITING

Boston Childrens Hospital, Boston

37212-3157

RECRUITING

Vanderbilt University Medical Center, Nashville

K1H 8L1

RECRUITING

Childrens Hospital of Eastern Ontario, Ottawa

H3T 1C5

RECRUITING

Centre Hospitalier Universitaire Sainte Justine, Montreal

700-0013

RECRUITING

Okayama Saiseikai Outpatient Center Hospital, Okayama

700-8558

RECRUITING

Okayama University Hospital, Okayama

594-1101

RECRUITING

Osaka Womens and Childrens Hospital, Izumi-shi

157-8535

RECRUITING

National Center for Child Health and Development, Setagaya-ku

31-530

RECRUITING

Centermed Krakow Sp zoo, Krakow

91-738

RECRUITING

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds, Lodz

93-338

RECRUITING

Instytut Centrum Zdrowia Matki Polki, Lodz

43-100

RECRUITING

Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia, Tychy

833 40

RECRUITING

Narodny ustav detskych chorob, Bratislava

08035

RECRUITING

Hospital Universitari Vall d Hebron, Barcelona

08950

RECRUITING

Hospital Sant Joan de Deu, Esplugues de Llorbregat

06500

RECRUITING

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara

G51 4TF

RECRUITING

Queen Elizabeth University Hospital, Glasgow

M13 9WL

RECRUITING

Royal Manchester Childrens Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY