274. 骨形成不全症
［臨床試験数：78，薬物数：87（DrugBank：19），標的遺伝子数：14，標的パスウェイ数：74］
Searched query = "Osteogenesis Imperfecta"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-000550-21-BG (EUCTR) | 01/12/2020 | 11/09/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 2 | EUCTR2018-000550-21-DE (EUCTR) | 18/09/2020 | 20/02/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 3 | EUCTR2018-000550-21-ES (EUCTR) | 01/10/2019 | 05/07/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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] | Amgen Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 4 | EUCTR2018-000550-21-GB (EUCTR) | 07/03/2019 | 17/06/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 5 | NCT03638128 (ClinicalTrials.gov) | July 26, 2018 | 21/6/2018 | Open-label Extension Denosumab Study in Children and Young Adults With Osteogenesis Imperfecta | Multicenter, 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) | Drug: Denosumab | Amgen | NULL | Recruiting | 5 Years | 20 Years | All | 150 | Phase 3 | United States;Belgium;Canada;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2018-000550-21-HU (EUCTR) | 06/07/2018 | 10/05/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 7 | NCT02352753 (ClinicalTrials.gov) | June 24, 2015 | 28/1/2015 | Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI | To 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 OI | Osteogenesis Imperfecta | Drug: Denosumab | Amgen | NULL | Active, not recruiting | 2 Years | 17 Years | All | 153 | Phase 3 | United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom;Czech Republic |
| 8 | EUCTR2014-000184-40-BE (EUCTR) | 22/05/2015 | 23/02/2015 | Study 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Hungary;France;United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Bulgaria;Germany;United Kingdom | ||
| 9 | EUCTR2014-000184-40-GB (EUCTR) | 30/01/2015 | 26/08/2014 | Study 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | ||
| 10 | EUCTR2014-000184-40-DE (EUCTR) | 29/12/2014 | 22/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Belgium;Spain;Poland;Australia;Bulgaria;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2014-000184-40-ES (EUCTR) | 19/10/2014 | 01/09/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | France;United States;Hungary;Czech Republic;Canada;Finland;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | |||
| 12 | EUCTR2014-000184-40-HU (EUCTR) | 18/10/2014 | 29/08/2014 | Study 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: 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | ||
| 13 | EUCTR2014-000184-40-CZ (EUCTR) | 11/09/2014 | 12/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | ||
| 14 | EUCTR2012-002887-29-DE (EUCTR) | 13/02/2013 | 07/11/2012 | New therapeutic approach in OI with the antibody Denosumab | Translational 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 Cologne | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 15 | NCT01799798 (ClinicalTrials.gov) | February 2013 | 14/2/2013 | Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab | TRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMAB | Osteogenesis Imperfecta | Drug: Denosumab | University of Cologne | NULL | Completed | 5 Years | 11 Years | Both | 10 | Phase 2 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2014-000184-40-PL (EUCTR) | 15/01/2015 | Study 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. | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany | |||
| 17 | EUCTR2014-000184-40-Outside-EU/EEA (EUCTR) | 26/11/2014 | Study 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: 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. | NULL | NA | Female: yes Male: yes | 150 | United States;Australia;Canada | ||||
| 18 | EUCTR2014-000184-40-FR (EUCTR) | 18/06/2015 | Study 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] | Amgen, Inc. | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | ||||
| 19 | EUCTR2018-000550-21-BE (EUCTR) | 14/01/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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] | Amgen Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||||
| 20 | EUCTR2018-000550-21-CZ (EUCTR) | 14/02/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2018-000550-21-FR (EUCTR) | 27/07/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 22 | EUCTR2018-000550-21-PL (EUCTR) | 16/10/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | |||
| 23 | EUCTR2014-000184-40-BG (EUCTR) | 05/12/2014 | Study 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] | Amgen, Inc. | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom |