Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

January 21, 2021

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Osteogenesis Imperfecta
Interventions
DRUG

Romosozumab

Participants will receive multiple doses of romosozumab via a SC injection.

DIETARY_SUPPLEMENT

Calcium

All participants will receive daily supplements of elemental calcium.

DIETARY_SUPPLEMENT

Vitamin D

All participants will receive daily supplementation with vitamin D.

Trial Locations (15)

1094

Semmelweis Egyetem, Budapest

4020

Kepler Universitaetsklinikum GmbH, Linz

11527

General Children Hospital Panagioti and Aglaias Kyriakou, Athens

28905

Hospital Universitario de Getafe, Getafe

34010

Koc Universitesi Hastanesi, Istanbul

35100

Ege Universitesi Ilac Gelistirme ve Farmakokinetik Arastirma Uygulama Merkezi (ARGEFAR), Izmir

46026

Hospital Universitari i Politecnic La Fe, Valencia

46202

Riley Hospital for Children, Indianapolis

48903

Hospital de Cruces, Barakaldo

50937

Uniklinik Köln, Cologne

53226

The Medical College of Wisconsin, Milwaukee

37212-3157

Vanderbilt University Medical Center, Nashville

00165

IRCCS Ospedale Pediatrico Bambino Gesu, Roma

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

06500

Gazi Universitesi Tip Fakultesi, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY