274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details


臨床試験数 : 87 薬物数 : 105 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76

  
25 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000550-21-BG
(EUCTR)
01/12/202011/09/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
2EUCTR2014-000184-40-PL
(EUCTR)
13/10/202015/01/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
3EUCTR2018-000550-21-DE
(EUCTR)
18/09/202020/02/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - Prolia Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
4EUCTR2018-000550-21-CZ
(EUCTR)
31/03/202014/02/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
5EUCTR2018-000550-21-ES
(EUCTR)
01/10/201905/07/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
6EUCTR2018-000550-21-IT
(EUCTR)
21/06/201915/06/2021Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Children/Young Adults with OsteogenesisImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - NA Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: [AMG 162]
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany
7EUCTR2018-000550-21-GB
(EUCTR)
07/03/201917/06/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
8NCT03638128
(ClinicalTrials.gov)
July 26, 201821/6/2018Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis ImperfectaOsteogenesis Imperfecta (OI)Drug: Denosumab;Other: No treatment;Drug: Alternative osteoporosis medicationsAmgenNULLActive, not recruiting5 Years20 YearsAll75Phase 3United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom
9EUCTR2018-000550-21-HU
(EUCTR)
06/07/201810/05/2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
10NCT02352753
(ClinicalTrials.gov)
June 24, 201528/1/2015Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OITo Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OIOsteogenesis ImperfectaDrug: DenosumabAmgenNULLActive, not recruiting2 Years17 YearsAll153Phase 3United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom;Czech Republic
11EUCTR2014-000184-40-BE
(EUCTR)
22/05/201523/02/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
12EUCTR2014-000184-40-GB
(EUCTR)
30/01/201526/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom
13EUCTR2014-000184-40-DE
(EUCTR)
29/12/201422/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
14EUCTR2014-000184-40-ES
(EUCTR)
19/10/201401/09/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 17.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
15EUCTR2014-000184-40-HU
(EUCTR)
18/10/201429/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 19.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
16EUCTR2014-000184-40-CZ
(EUCTR)
11/09/201412/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
17EUCTR2012-002887-29-DE
(EUCTR)
13/02/201307/11/2012New therapeutic approach in OI with the antibody DenosumabTranslational therapy in patients with Osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AK In this study we will evaluate the efficacy of Denosumab in children with Osteogenesis imperfecta. Subjects will be treated every 12 weeks over 36 weeks with Denosumab 1mg/kg body weight s.c.. Efficacy will be evaluated by DXA measurements of the spine for bone mineral density.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Prolia
Product Name: Denusomab
INN or Proposed INN: DENOSUMAB
Other descriptive name: DENOSUMAB
University of CologneNULLNot RecruitingFemale: yes
Male: yes
Germany
18NCT01799798
(ClinicalTrials.gov)
February 201314/2/2013Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody DenosumabTRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMABOsteogenesis ImperfectaDrug: DenosumabUniversity of CologneNULLCompleted5 Years11 YearsBoth10Phase 2Germany
19EUCTR2014-000184-40-BG
(EUCTR)
05/12/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
20EUCTR2014-000184-40-IT
(EUCTR)
15/06/2021Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta - Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in OSTEOGENESIS IMPERFECTA
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA - 120 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 1.7 ML 4 FLACONCINI
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: DENOSUMAB
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
AMGEN INC.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
21EUCTR2014-000184-40-Outside-EU/EEA
(EUCTR)
26/11/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 17.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: denosumab - - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen Inc.NULLNAFemale: yes
Male: yes
150United States;Australia;Canada
22EUCTR2018-000550-21-PL
(EUCTR)
16/10/2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
23EUCTR2018-000550-21-FR
(EUCTR)
27/07/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNAFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
24EUCTR2014-000184-40-FR
(EUCTR)
18/06/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNA Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
25EUCTR2018-000550-21-BE
(EUCTR)
14/01/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNAFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany