274. Osteogenesis Imperfecta Clinical trials / Disease details

Clinical trials : 87 / Drugs : 103 - (DrugBank : 20) / Drug target genes : 14 - Drug target pathways : 76

5 trials found

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	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	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	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
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	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
5	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