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 | NCT04152551 (ClinicalTrials.gov) | November 2, 2019 | 18/10/2019 | Effects of Bisphosphonates on OI-Related Hearing Loss | Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study | Osteogenesis Imperfecta | Drug: Risedronate Oral Tablet | Hospital for Special Surgery, New York | The New York Community Trust;Weill Medical College of Cornell University;Northwell Health | Recruiting | 6 Years | 100 Years | All | 100 | Phase 4 | United States |
| 3 | 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 | ||
| 4 | NCT03208582 (ClinicalTrials.gov) | April 1, 2017 | 23/5/2017 | Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta? | Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta? | Osteogenesis Imperfecta | Drug: Risedronate Sodium;Dietary Supplement: Calcichew tablets | Sheffield Children's NHS Foundation Trust | NULL | Completed | 4 Years | 16 Years | All | 13 | Phase 2 | United Kingdom |
| 5 | EUCTR2016-003606-14-GB (EUCTR) | 31/01/2017 | 17/10/2016 | Brittle bones - do they react normally after treatment with bisphosphonates? | Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta? - BAMES study | 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: Actonel 5mg Film Coated Tablets Product Name: Actonel 5mg Film Coated Tablets INN or Proposed INN: Risedronate Sodium Trade Name: Actonel Once a Week 35 mg film-coated tablets Product Name: Actonel Once a Week 35 mg film-coated tablets INN or Proposed INN: Risedronate Sodium | Sheffield Children's NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | United Kingdom | ||
| 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 | EUCTR2004-000485-13-DK (EUCTR) | 29/01/2007 | 29/11/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta MedDRA version: 8.1;Level: LLT;Classification code 10031243;Term: Osteogenesis imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Trade Name: Optinate 5 mg filmcoated tablets Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 8 | EUCTR2004-000485-13-CZ (EUCTR) | 04/10/2006 | 25/08/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 9 | EUCTR2004-000485-13-HU (EUCTR) | 25/08/2006 | 14/07/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Finland;Hungary;Czech Republic;Denmark;Spain | |||
| 10 | EUCTR2004-000485-13-BE (EUCTR) | 22/08/2006 | 30/05/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Czech Republic;Hungary;Finland;Spain;Belgium;Denmark | |||
| 11 | EUCTR2004-000485-13-FI (EUCTR) | 28/03/2006 | 10/02/2006 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE | Osteogenesis Imperfecta | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Trade Name: Actonel/Optinate 5mg film-coated tablets Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 12 | NCT00106028 (ClinicalTrials.gov) | November 2004 | 18/3/2005 | Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children | Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children | Osteogenesis Imperfecta | Drug: risedronate sodium (Actonel);Drug: Placebo | Warner Chilcott | NULL | Completed | 4 Years | 15 Years | All | 143 | Phase 3 | United States;Australia;Belgium;Chile;Czech Republic;Finland;Germany;Hungary;Italy;Poland;South Africa;Spain;United Kingdom |