Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

PHASE3TerminatedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

June 24, 2015

Primary Completion Date

March 26, 2022

Study Completion Date

March 26, 2022

Conditions
Osteogenesis Imperfecta
Interventions
DRUG

Denosumab

Subcutaneous (SC) injection.

Trial Locations (49)

1094

Research Site, Budapest

1200

Research Site, Brussels

1606

Research Site, Sofia

1784

Research Site, Sofia

2145

Research Site, Westmead

3000

Research Site, Leuven

6008

Research Site, Subiaco

9000

Research Site, Ghent

9010

Research Site, Varna

19803

Research Site, Wilmington

21205

Research Site, Baltimore

28905

Research Site, Getafe

30033

Research Site, Decatur

31059

Research Site, Toulouse

33076

Research Site, Bordeaux

37126

Research Site, Verona

37232

Research Site, Nashville

42270

Research Site, Saint-Priest-en-Jarez

46026

Research Site, Valencia

46202

Research Site, Indianapolis

50931

Research Site, Cologne

52242

Research Site, Iowa City

68114

Research Site, Omaha

75012

Research Site, Paris

75743

Research Site, Paris

77030

Research Site, Houston

80045

Research Site, Aurora

90027

Research Site, Los Angeles

90502

Research Site, Torrance

06510

Research Site, New Haven

02115

Research Site, Boston

K1H 8L1

Research Site, Ottawa

M5G 1X8

Research Site, Toronto

H4A 0A9

Research Site, Montreal

500 05

Research Site, Hradec Králové

532 03

Research Site, Pardubice

305 99

Research Site, Pilsen

140 59

Research Site, Prague

762 75

Research Site, Zlín

00161

Research Site, Roma

15-274

Research Site, Bialystok

91-738

Research Site, Lodz

35-301

Research Site, Rzeszów

04-730

Research Site, Warsaw

08950

Research Site, Esplugues de Llobregat

B4 6NH

Research Site, Birmingham

BS2 8AE

Research Site, Bristol

G51 4TF

Research Site, Glasgow

S10 2TH

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT02352753 - Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI | Biotech Hunter | Biotech Hunter