274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details


臨床試験数 : 87 薬物数 : 105 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76

  
17 trials found
No.TrialIDDate_
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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
2EUCTR2016-005096-27-GB
(EUCTR)
25/08/201719/02/2018A 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.NULLAuthorised-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): noFrance;United States;Canada;Denmark;United Kingdom
3EUCTR2016-005096-27-DK
(EUCTR)
23/06/201724/03/2017A 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;France;Canada;Denmark;United Kingdom
4EUCTR2016-003228-22-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
5NCT03169192
(ClinicalTrials.gov)
June 1, 201725/5/2017Diagnosis of Osteogenesis Imperfecta in ChildrenMolecular Genetic Study of Suspected Cases of Osteogenesis Imperfecta Attending Assiut University Children HospitalBone Disease, MetabolicDrug: Zoledronic AcidAssiut UniversityNULLNot yet recruiting1 Month18 YearsAll40N/AEgypt
6EUCTR2016-003228-22-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 4Ireland;United Kingdom
7NCT03735537
(ClinicalTrials.gov)
November 1, 20169/8/2018Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic AcidTreatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic AcidOsteogenesis ImperfectaDrug: Teriparatide Pen Injector;Drug: Zoledronic AcidUniversity of EdinburghNHS LothianRecruiting18 YearsN/AAll380Phase 4Ireland;United Kingdom
8EUCTR2011-000745-21-BE
(EUCTR)
10/12/201218/09/2012An international, multicenter, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfectaAn 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 ChildrenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United States;Canada;Belgium
9NCT01679080
(ClinicalTrials.gov)
November 201216/8/2012The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis ImperfectaThe Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic acid;Drug: Teriparatide;Other: No active treatmentUniversity of AarhusNULLTerminated22 Years70 YearsAll9Phase 2Denmark
10EUCTR2011-002811-27-DK
(EUCTR)
07/11/201104/11/2011The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis ImperfectaThe 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, DMScNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Denmark
11NCT00982124
(ClinicalTrials.gov)
October 200721/9/2009An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis ImperfectaAn International, Multicenter, Open-label, Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidShriners Hospitals for ChildrenNovartisCompletedN/A12 MonthsBoth14Phase 3Canada
12EUCTR2004-001666-40-GB
(EUCTR)
14/06/200513/05/2005An 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 - 2202EAn 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 ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
130Hungary;United Kingdom
13EUCTR2004-001666-40-HU
(EUCTR)
01/02/200525/11/2004An 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 - 2202EAn 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 ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
130Hungary;United Kingdom
14NCT00131118
(ClinicalTrials.gov)
July 200415/8/2005Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis ImperfectaEfficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidNovartis PharmaceuticalsNULLCompleted1 Year17 YearsAll127Phase 2United States
15NCT00063479
(ClinicalTrials.gov)
June 200327/6/2003Bisphosphonate Treatment of Osteogenesis ImperfectaBisphosphonate Treatment of Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidNovartis PharmaceuticalsNULLCompleted3 Months17 YearsAll158Phase 2United States;Germany
16EUCTR2015-003539-37-Outside-EU/EEA
(EUCTR)
07/03/2016Bisphosphonate Treatment of Osteogenesis ImperfectaAn 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: ZometaNovartisNULLNAFemale: yes
Male: yes
158United States
17EUCTR2004-001666-40-BE
(EUCTR)
05/09/2005An 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 - 2202EAn 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 ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Belgium;United Kingdom