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［原発性胆汁性肝硬変 (~2017.3)］ | 1 |
| 95 | 自己免疫性肝炎 | 1 |
| 274 | 骨形成不全症 | 5 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000012193 | 2013/11/01 | 01/11/2013 | Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis | Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonate | Discontinue 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 Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not applicable | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000013659 | 2014/04/08 | 08/04/2014 | Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (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 Medicine | NULL | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 80 | Not applicable | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2004-000485-13-DK (EUCTR) | 29/01/2007 | 29/11/2006 | A 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 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 2 | EUCTR2004-000485-13-CZ (EUCTR) | 04/10/2006 | 25/08/2006 | A 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 | A 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 | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 3 | EUCTR2004-000485-13-HU (EUCTR) | 25/08/2006 | 14/07/2006 | A 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 | A 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 | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Finland;Hungary;Czech Republic;Denmark;Spain | |||
| 4 | EUCTR2004-000485-13-BE (EUCTR) | 22/08/2006 | 30/05/2006 | A 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 | A 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 | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Czech Republic;Hungary;Finland;Spain;Belgium;Denmark | |||
| 5 | EUCTR2004-000485-13-FI (EUCTR) | 28/03/2006 | 10/02/2006 | A 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 | A 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 | Product 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain |