Prolia (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 274 | 骨形成不全症 | 3 |
| 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-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 | ||
| 2 | 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 | ||
| 3 | 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 |