274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details
臨床試験数 : 87 / 薬物数 : 103 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76
Showing 1 to 10 of 87 diseases
| 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 | NCT05231668 (ClinicalTrials.gov) | March 4, 2022 | 31/1/2022 | Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI) | A Phase 1b, Single Ascending Dose, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Activity of SAR439459 in Adults With Osteogenesis Imperfecta A Phase 1b, Single Ascending Dose, Randomized, Double-blind Study to Evaluate the Safety, Tolerabili ... | Osteogenesis Imperfecta | Drug: SAR439459;Drug: Placebo | Sanofi | NULL | Not yet recruiting | 18 Years | 65 Years | All | 24 | Phase 1 | NULL |
| 2 | NCT05125809 (ClinicalTrials.gov) | February 21, 2022 | 8/11/2021 | Study to Assess the Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta | A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Efficacy and Safety of ... | Osteogenesis Imperfecta | Biological: Setrusumab;Other: Placebo | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | Recruiting | 5 Years | 25 Years | All | 195 | Phase 2/Phase 3 | United States;Australia;Canada;Denmark;Italy;United Kingdom |
| 3 | EUCTR2017-004972-74-DE (EUCTR) | 20/07/2021 | 22/07/2020 | An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and ... | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorderscharacterized by increased bone fragility, low bone mass , and increasedbone turnover contributing to osteoporosis, fractures, and otherconditions. OI is the most common form of primary osteoporosis inchildren with an estimated incidence of 1 per 25,000 live births. MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta(OI) is a group of genetic skeletal disorderscharacterized by increased bone ... | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name ... | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 4 | EUCTR2017-004972-74-GR (EUCTR) | 19/02/2021 | 18/12/2020 | An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and ... | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorderscharacterized by increased bone fragility, low bone mass , and increasedbone turnover contributing to osteoporosis, fractures, and otherconditions. OI is the most common form of primary osteoporosis inchildren with an estimated incidence of 1 per 25,000 live births. MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta(OI) is a group of genetic skeletal disorderscharacterized by increased bone ... | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name ... | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 5 | NCT04545554 (ClinicalTrials.gov) | January 21, 2021 | 4/9/2020 | Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | Osteogenesis Imperfecta | Drug: Romosozumab;Dietary Supplement: Calcium;Dietary Supplement: Vitamin D | Amgen | NULL | Recruiting | 5 Years | 17 Years | All | 16 | Phase 1 | United States;Germany;Greece;Hungary;Italy;Spain;Turkey |
| 6 | EUCTR2016-003228-22-NL (EUCTR) | 13/01/2021 | 27/11/2020 | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ study | 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: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | Trade Name: Teriparatide Product Name: Teriparatide Trade Name: Zoledronic acid Product Name: Zoledronic acid Trade Name: Alendronic acid Product Name: Alendronic acid Trade Name: Risedronate sodium Product Name: Risedronate sodium Trade Name: Ibandronic acid Product Name: Ibandronic acid Trade Name: Ibandronic acid Product Name: Ibandronic acid Trade Name: Disodium Pamidronate 15mg (15mg strength) Product Name: Disodium Pamidronate 15mg (15mg strength) Trade Name: Prolia Product Name: Prolia Trade Name: Bonefos Product Name: Bonefos Trade Name: Teriparatide Product Name: Teriparatide Trade Name: Zoledronic acid Product Name: Zoledroni ... | University of Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;Netherlands;United Kingdom | ||
| 7 | 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 Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Childr ... | 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 Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | 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] Osteogenesis Imperfecta(OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteog ... | 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 Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Austral ... | ||
| 8 | EUCTR2017-004972-74-IT (EUCTR) | 21/10/2020 | 21/01/2021 | An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta - NA An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and ... | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorders characterized by increased bone fragility, low bone mass, and increased bone turnover contributing to osteoporosis, fractures, and other conditions. OI is the most common form of primary osteoporosis in children with an estimated incidence of 1 per 25,000 live births. MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Osteogenesis imperfecta(OI) is a group of genetic skeletal disorders characterized by increased bone ... | Trade Name: Evenity 105mg Product Name: Romosozumab Product Code: [AMG 785] INN or Proposed INN: ROMOSOZUMAB Trade Name: CALCIUM D3 SANDOZ - 1000 MG + 880 U.I. COMPRESSE EFFERVESCENTI 30 COMPRESSE DIVISIBILI Product Name: Calcium D3 Product Code: [vitamina D e calcio] INN or Proposed INN: CALCIO CARBONATO/COLECALCIFEROLO Trade Name: Evenity105mg Product Name: Romosozumab Product Code: [AMG 785] INN or Proposed INN: ROMOSOZ ... | AMGEN INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 9 | EUCTR2014-000184-40-PL (EUCTR) | 13/10/2020 | 15/01/2015 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ... | Prospective, Multicenter, Single-arm 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 Den ... | 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] Osteogenesis Imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | 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 Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium ... | ||
| 10 | 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 Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Childr ... | 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 Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Curren ... | 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] Osteogenesis Imperfecta(OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteog ... | 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 Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 INN or Proposed INN: Denosumab Other des ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland ... |