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5

274. 骨形成不全症


臨床試験数 : 91 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-003228-22-NL
(EUCTR)
13/01/202127/11/2020Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acidTreatment 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 EdinburghNHS LothianAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Ireland;Netherlands;United Kingdom
2EUCTR2018-000550-21-DE
(EUCTR)
18/09/202020/02/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, 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 IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
3EUCTR2016-003228-22-IE
(EUCTR)
22/06/201703/11/2016Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acidTreatment 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 EdinburghNHS LothianAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Ireland;Netherlands;United Kingdom
4EUCTR2016-003228-22-GB
(EUCTR)
14/12/201619/10/2016Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acidTreatment 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 EdinburghNHS LothianAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Netherlands;Ireland;Denmark;United Kingdom
5EUCTR2012-002887-29-DE
(EUCTR)
13/02/201307/11/2012New therapeutic approach in OI with the antibody DenosumabTranslational 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 CologneNULLNot RecruitingFemale: yes
Male: yes
Germany