Risedronic acid ( DrugBank: Risedronic acid )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎1
95自己免疫性肝炎1
274骨形成不全症5

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000012193
2013/11/0101/11/2013Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosisEfficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis - Denosumab versus Bisphosphonate for osteoporosis in patients with PBC Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonateDiscontinue the administration of aredoron acid, risedronic acid, and minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not applicableJapan

95. 自己免疫性肝炎


臨床試験数 : 52 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000013659
2014/04/0808/04/2014Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) - Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months<Test A; Randomization test: 1)2)>
In patients pretreated with bisphosphonates;
1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.

<Test A; Randomization test: 1)2)>
2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.

<Test B; newly intervention>
In patients who were not pretreated with bisphosphonates; 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Juntendo University School of MedicineNULLComplete: follow-up continuing20years-old75years-oldMale and Female80Not applicableJapan

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
1EUCTR2004-000485-13-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
2EUCTR2004-000485-13-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 LtdNULLNot RecruitingFemale: yes
Male: yes
124Phase 3Hungary;Czech Republic;Finland;Spain;Belgium;Denmark
3EUCTR2004-000485-13-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
4EUCTR2004-000485-13-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
5EUCTR2004-000485-13-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