Risedronate ( DrugBank: Risedronate )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ1
50皮膚筋炎/多発性筋炎1
66IgA腎症1
96クローン病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12

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000015794
2014/12/1510/12/2014Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) osteoporosis, rheumatoid arthritismonthly risedronate sodium 75mg for 6 months
monthly placebo for 6 months
Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of MedicineNULLComplete: follow-up continuing20years-oldNot applicableMale and Female165Phase 4Japan

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

66. IgA腎症


臨床試験数 : 255 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000002474
2007/01/0101/10/2009Preventive effect of vit K, vit D and, risedronate on 3-dimensional trabecular microstructure in patients with IgA nephropathy on glucocorticoid treatment Glucocorticoid induced osteoporosis in patients with IgA nephropathyMenatetrenone 45mg/day for 6 months
Calcitriol 0.5 microgram/day for 6 months
Risedronate 17.5mg/week for 6 months
Osaka University HospitalDepartment of nephrologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female30Not applicableJapan

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01215890
(ClinicalTrials.gov)
September 20105/10/2010Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's DiseaseA Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease PatientsCrohn's Disease;Low Bone Mineral DensityDrug: risedronate;Drug: placeboUniversity of AlbertaNULLCompleted18 YearsN/ABothPhase 4Canada

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
2NCT04152551
(ClinicalTrials.gov)
November 2, 201918/10/2019Effects of Bisphosphonates on OI-Related Hearing LossEffects of Bisphosphonates on OI-Related Hearing Loss: A Pilot StudyOsteogenesis ImperfectaDrug: Risedronate Oral TabletHospital for Special Surgery, New YorkThe New York Community Trust;Weill Medical College of Cornell University;Northwell HealthRecruiting6 Years100 YearsAll100Phase 4United States
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
4NCT03208582
(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
5EUCTR2016-003606-14-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
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
7EUCTR2004-000485-13-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
8EUCTR2004-000485-13-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
9EUCTR2004-000485-13-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
10EUCTR2004-000485-13-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
11EUCTR2004-000485-13-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
12NCT00106028
(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