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
| 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 | 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] | 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 | University of Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;Netherlands;United Kingdom | ||
| 2 | EUCTR2016-005096-27-GB (EUCTR) | 25/08/2017 | 19/02/2018 | A study of test product setrusumab in adults with brittle bone syndrome. | A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). | 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] | Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product. INN or Proposed INN: ZOLEDRONIC ACID | Mereo Biopharma 3 Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Denmark;United Kingdom | ||
| 3 | EUCTR2016-005096-27-DK (EUCTR) | 23/06/2017 | 24/03/2017 | A study of test product setrusumab in adults with brittle bone syndrome. | A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). | 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] | Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion,generic medicinal product Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product. INN or Proposed INN: ZOLEDRONIC ACID | Mereo BioPharma 3 Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;France;Canada;Denmark;United Kingdom | ||
| 4 | EUCTR2016-003228-22-IE (EUCTR) | 22/06/2017 | 03/11/2016 | 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] | 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: Clasteon Product Name: Clasteon Trade Name: Calcichew D3 Product Name: Calcichew D3 Trade Name: Fultium-D3 800IU capsules Product Name: Fultium-D3 800IU capsules Trade Name: Prolia Product Name: Prolia | University of Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;Netherlands;United Kingdom | ||
| 5 | NCT03169192 (ClinicalTrials.gov) | June 1, 2017 | 25/5/2017 | Diagnosis of Osteogenesis Imperfecta in Children | Molecular Genetic Study of Suspected Cases of Osteogenesis Imperfecta Attending Assiut University Children Hospital | Bone Disease, Metabolic | Drug: Zoledronic Acid | Assiut University | NULL | Not yet recruiting | 1 Month | 18 Years | All | 40 | N/A | Egypt |
| 6 | EUCTR2016-003228-22-GB (EUCTR) | 14/12/2016 | 19/10/2016 | 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] | 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 | University of Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;United Kingdom | ||
| 7 | NCT03735537 (ClinicalTrials.gov) | November 1, 2016 | 9/8/2018 | Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid | Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid | Osteogenesis Imperfecta | Drug: Teriparatide Pen Injector;Drug: Zoledronic Acid | University of Edinburgh | NHS Lothian | Recruiting | 18 Years | N/A | All | 380 | Phase 4 | Ireland;United Kingdom |
| 8 | EUCTR2011-000745-21-BE (EUCTR) | 10/12/2012 | 18/09/2012 | An international, multicenter, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta | An international, multicenter, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta - SHC - INFOI | Children suffering from severe Osteogenesis Imperfecta MedDRA version: 14.1;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: ACLASTA Product Name: zoledronic acid INN or Proposed INN: RITUXIMAB | Schriners Hospitals for Children | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | United States;Canada;Belgium | |||
| 9 | NCT01679080 (ClinicalTrials.gov) | November 2012 | 16/8/2012 | The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta | The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic acid;Drug: Teriparatide;Other: No active treatment | University of Aarhus | NULL | Terminated | 22 Years | 70 Years | All | 9 | Phase 2 | Denmark |
| 10 | EUCTR2011-002811-27-DK (EUCTR) | 07/11/2011 | 04/11/2011 | The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta | The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatment | Osteogenesis imperfecta;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Forsteo Product Code: H05AA02 Trade Name: Aclasta | Bente Langdahl, consultant, ass. professor, PhD, DMSc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Denmark | ||
| 11 | NCT00982124 (ClinicalTrials.gov) | October 2007 | 21/9/2009 | An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta | An International, Multicenter, Open-label, Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Shriners Hospitals for Children | Novartis | Completed | N/A | 12 Months | Both | 14 | Phase 3 | Canada |
| 12 | EUCTR2004-001666-40-GB (EUCTR) | 14/06/2005 | 13/05/2005 | An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E | An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E | Osteogenesis Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Hungary;United Kingdom | |||
| 13 | EUCTR2004-001666-40-HU (EUCTR) | 01/02/2005 | 25/11/2004 | An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E | An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E | Osteogenesis Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Hungary;United Kingdom | |||
| 14 | NCT00131118 (ClinicalTrials.gov) | July 2004 | 15/8/2005 | Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta | Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Novartis Pharmaceuticals | NULL | Completed | 1 Year | 17 Years | All | 127 | Phase 2 | United States |
| 15 | NCT00063479 (ClinicalTrials.gov) | June 2003 | 27/6/2003 | Bisphosphonate Treatment of Osteogenesis Imperfecta | Bisphosphonate Treatment of Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Novartis Pharmaceuticals | NULL | Completed | 3 Months | 17 Years | All | 158 | Phase 2 | United States;Germany |
| 16 | EUCTR2004-001666-40-BE (EUCTR) | 05/09/2005 | An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E | An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E | Osteogenesis Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | Hungary;Belgium;United Kingdom | |||
| 17 | EUCTR2015-003539-37-Outside-EU/EEA (EUCTR) | 07/03/2016 | Bisphosphonate Treatment of Osteogenesis Imperfecta | An international, multicenter, randomized, open-label, parallel efficacy, and safety trial of intravenous zoledronic acid compared to intravenous pamidronate in children with severe osteogenesis imperfect. | Osteogenesis Imperfecta;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Zometa | Novartis | NULL | NA | Female: yes Male: yes | 158 | United States |