Risedronate Sodium ( DrugBank: Risedronate )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
50皮膚筋炎/多発性筋炎1
107若年性特発性関節炎1
113筋ジストロフィー1
274骨形成不全症11

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 182 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-003129-23-GB
(EUCTR)
18/04/200624/02/2006To prevent and treat osteoporosis in children with rhuematic diseases taking steroidsPrevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) Vasculitis;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Risedronate Sodium
Product Code: 35mg
Other descriptive name: RISEDRONATE SODIUM
Product Name: Risedronate Sodium
Product Code: 5mg
Other descriptive name: RISEDRONATE SODIUM
Trade Name: One-Alpha drops
Product Name: One Alpha Drops
Product Code: alfacalcidol 2 micrograms/ml
INN or Proposed INN: ALFACALCIDOL
Other descriptive name: drops
Belfast Health and Social Care Trust, Musgrave Park HospitalNULLNot Recruiting Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom

107. 若年性特発性関節炎


臨床試験数 : 441 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-003129-23-GB
(EUCTR)
18/04/200624/02/2006To prevent and treat osteoporosis in children with rhuematic diseases taking steroidsPrevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) Vasculitis;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: Risedronate Sodium
Product Code: 35mg
Other descriptive name: RISEDRONATE SODIUM
Product Name: Risedronate Sodium
Product Code: 5mg
Other descriptive name: RISEDRONATE SODIUM
Trade Name: One-Alpha drops
Product Name: One Alpha Drops
Product Code: alfacalcidol 2 micrograms/ml
INN or Proposed INN: ALFACALCIDOL
Other descriptive name: drops
Belfast Health and Social Care Trust, Musgrave Park HospitalNULLNot Recruiting Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom

113. 筋ジストロフィー


臨床試験数 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-017649-67-IE
(EUCTR)
22/06/201013/01/2010Bone Health in Duchenne Muscular Dystrophy- a case controlled study of Risedronate use - Risedronate in DMDBone Health in Duchenne Muscular Dystrophy- a case controlled study of Risedronate use - Risedronate in DMD Bone Health in Duchenne Muscular Dystrophy- a randomised controlled study of Risedronate useTrade Name: Actonel Once a week 5mg film coated tablets
Product Name: Risedronate sodium
Product Code: Risedronate
Trade Name: Calcichew D3 Forte
Product Name: Calcichew D3 Forte
Product Code: Calcichew D3 Forte
The Central Remedial Clinic and The Children's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Ireland

274. 骨形成不全症


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.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
2EUCTR2016-003228-22-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
3NCT03208582
(ClinicalTrials.gov)
April 1, 201723/5/2017Do 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 ImperfectaDrug: Risedronate Sodium;Dietary Supplement: Calcichew tabletsSheffield Children's NHS Foundation TrustNULLCompleted4 Years16 YearsAll13Phase 2United Kingdom
4EUCTR2016-003606-14-GB
(EUCTR)
31/01/201717/10/2016Brittle 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 TrustNULLNot RecruitingFemale: yes
Male: yes
15Phase 2United Kingdom
5EUCTR2016-003228-22-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
6EUCTR2004-000485-13-DK
(EUCTR)
29/01/200729/11/2006A 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. - POISEA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
7EUCTR2004-000485-13-CZ
(EUCTR)
04/10/200625/08/2006A 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. - POISEA 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 ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
8EUCTR2004-000485-13-HU
(EUCTR)
25/08/200614/07/2006A 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. - POISEA 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 ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLNot RecruitingFemale: yes
Male: yes
124Finland;Hungary;Czech Republic;Denmark;Spain
9EUCTR2004-000485-13-BE
(EUCTR)
22/08/200630/05/2006A 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. - POISEA 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 ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLNot RecruitingFemale: yes
Male: yes
124Czech Republic;Hungary;Finland;Spain;Belgium;Denmark
10EUCTR2004-000485-13-FI
(EUCTR)
28/03/200610/02/2006A 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. - POISEA 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 ImperfectaProduct 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 LtdNULLNot RecruitingFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
11NCT00106028
(ClinicalTrials.gov)
November 200418/3/2005Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in ChildrenSafety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in ChildrenOsteogenesis ImperfectaDrug: risedronate sodium (Actonel);Drug: PlaceboWarner ChilcottNULLCompleted4 Years15 YearsAll143Phase 3United States;Australia;Belgium;Chile;Czech Republic;Finland;Germany;Hungary;Italy;Poland;South Africa;Spain;United Kingdom