Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 7, 2018

Primary Completion Date

December 13, 2021

Study Completion Date

December 20, 2023

Conditions
Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects WithGlucocorticoid-induced Osteoporosis
Interventions
DRUG

Denosumab

1mg/kg BW (up to a maximum of 60 mg) SC Q6M

OTHER

Placebo

SC Q6M placebo

Trial Locations (38)

1200

Cliniques Universtaire Saint Luc Universite Catholique de Louvain, Brussels

1784

Medical Centre Synexus Sofia EOOD, Sofia

6909

Perth Childrens Hospital, Nedlands

19803

AI Dupont Hospital for Children, Wilmington

20145

Istituto Auxologico Italiano Istituto di Ricovero e Cura a Carattere Scientifico, Milan

25240

Ataturk Universitesi Tip Fakultesi, Erzurum

34890

Marmara Universitesi Pendik Egitim Arastirma Hastanesi, Istanbul

35100

Ege Universitesi Tip Fakultesi, Izmir

43205

Nationwide Childrens Hospital, Columbus

44109

Metrohealth Medical Center, Cleveland

46202

Indiana University Hospital, Indianapolis

49100

CI Dnipropetrovsk Regional Children Clinical Hospital of Dnipropetrovsk Regional Council, Dnipro

50139

Azienda Ospedaliera Universitaria Meyer, Florence

55454

University of Minnesota Masonic Childrens Hospital Discovery Clinic, Minneapolis

61075

Communal Institution of Healthcare Kharkiv City Clinical Children Hospital 16, Kharkiv

90027

Childrens Hospital of Los Angeles, Los Angeles

110221

Solano y Terront Servicios Medicos Ltda - Unidad Integral de Endocrinologia Uniendo, Bogota

119991

FSAI Scientific Center of Childrens Health of MoH of the RF, Moscow

SBEI of HPE First Moscow state medical university na I M Sechenov of MoH of Russian Federation, Moscow

191025

LLC Medical Technologies, Saint Petersburg

590010

KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi

630007

SBHI of Novosibirsk region City Pediatric Clinical Hospital of Emergency Care, Novosibirsk

681004

Foscal Internacional-Fundacion Oftalmologica de Santander, Floridablanca

K1H 8L1

Childrens Hospital of Eastern Ontario, Ottawa

H3T 1C5

Centre Hospitalier Universitaire Sainte Justine, Montreal

050021

Center for Clinical and Basic Research Colombia, Medellín

500 025

Gandhi Medical College, Hyderabad

110 022

Sir Ganga Ram Hospital, New Delhi

632 004

Christian Medical College, Vellore

00161

Azienda Ospedaliera Policlinico Umberto I, Roma

03100

RM Pharma Specialists SA de CV, Mexico City

Lima 5

Instituto Nacional de Salud del Nino, Breña

040001

Centro Especializado de Enfermedades Neoplasicas, Arequipa

Callao 2

Hospital Nacional Alberto Sabogal Sologuren, Callao

Lima 27

Clinica Angloamericana, Lima

Lima27

Centro de Investigacion Ricardo Palma, Lima

06590

Ankara Universitesi Tip Fakultesi, Ankara

01025

National Childrens Specialized Hospital OHMATDYT, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT03164928 - Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis | Biotech Hunter | Biotech Hunter