Alendronate (DrugBank: Alendronate)
7 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 19 | ライソゾーム病 | 1 |
| 41 | 巨細胞性動脈炎 | 1 |
| 46 | 悪性関節リウマチ | 5 |
| 50 | 皮膚筋炎／多発性筋炎 | 1 |
| 271 | 強直性脊椎炎 | 1 |
| 274 | 骨形成不全症 | 3 |
| 299 | 嚢胞性線維症 | 3 |
| 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 | NCT00004488 (ClinicalTrials.gov) | October 1998 | 18/10/1999 | Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease | Gaucher's Disease;Osteopenia | Drug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferol | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 18 Years | 50 Years | Both | 82 | Phase 2 | United States;Israel |
| 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 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 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 | NCT02944799 (ClinicalTrials.gov) | December 2015 | 27/6/2016 | Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis | Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone Mass | Rheumatoid Arthritis;Osteoporosis | Drug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin D | University of Aarhus | NULL | Active, not recruiting | 18 Years | N/A | All | 69 | Phase 2 | Denmark |
| 2 | EUCTR2015-003638-28-DK (EUCTR) | 30/09/2015 | 28/08/2015 | Treatment of osteoporosis in patients with rheumatoid arthritis. | ALOSTRA Alendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA | Rheumatoid arthritis and osteoporosis MedDRA version: 20.0;Level: LLT;Classification code 10031289;Term: Osteoporosis, unspecified;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Denmark | |||
| 3 | NCT01770106 (ClinicalTrials.gov) | December 2012 | 3/1/2013 | RA Denosumab on Bone Microstructure Study | Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled Trial | Rheumatoid Arthritis | Drug: Denosumab;Drug: Alendronate | Chinese University of Hong Kong | NULL | Completed | 18 Years | 80 Years | Female | 40 | Phase 4 | Hong Kong |
| 4 | ChiCTR-TRC-09000473 | 2009-07-20 | 2009-07-15 | Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial. | Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial. | Rheumatoid Arthritis | Group B:MTX 7.5-20mg, orally taken once weekly for 48 week;Group A:MTX7.5-20mg, orally taken once weekly combined Alendronate Sodium 70mg,orally taken once weekly for 48 weeks ; | People's Hospital, Peking University | NULL | Completed | 18 | Both | Group B:160;Group A:160; | China | ||
| 5 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 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 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. | Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 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 | NCT01104987 (ClinicalTrials.gov) | October 2009 | 13/4/2010 | Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS) | Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective Trial | Ankylosing Spondylitis;Osteoporosis | Drug: alendronate | Göteborg University | NULL | Completed | 18 Years | 80 Years | Both | 16 | Sweden |
| 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-UMIN000010615 | 2013/04/30 | 30/04/2013 | Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form) | Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form) - Alendronate infusion for osteogenesis imperfecta | osteogenesis imperfecta | Eighteen micrograms (2 ml)/kg of alendronate will be infused in 1 hour every 4 weeks. The study duration is 6 months. When the patient's BMD reaches to the normal range for age, treatment with alendronate will be finished. When the patient's BMD does not reach to the normal range for age, alendronate will be continued for another 6 months. | Tohoku University School of Medicine, Department of Pediatrics | NULL | Complete: follow-up continuing | Not applicable | 15years-old | Male and Female | 10 | Not applicable | Japan |
| 2 | NCT02303873 (ClinicalTrials.gov) | March 2007 | 19/11/2014 | Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta | Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study | Osteogenesis Imperfecta | Drug: Alendronate | Peking Union Medical College Hospital | National Natural Science Foundation of China | Completed | N/A | 18 Years | Both | 99 | Phase 4 | NULL |
| 3 | NCT00159419 (ClinicalTrials.gov) | August 1999 | 7/9/2005 | Bisphosphonate Therapy for Osteogenesis Imperfecta | Bisphosphonate Therapy for Osteogenesis Imperfecta | Osteogenesis Imperfecta;Osteoporosis;Paget Disease of Bone | Drug: Alendronate;Drug: Pamidronate | Indiana University School of Medicine | NULL | Completed | 3 Years | 21 Years | All | 18 | Phase 4 | United States |
| 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 | NCT00157690 (ClinicalTrials.gov) | December 2003 | 8/9/2005 | Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients | A Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis Patients | Cystic Fibrosis;Osteoporosis;Bone Diseases, Metabolic | Drug: Alendronate;Drug: Placebo | McMaster University | Centre hospitalier de l'Université de Montréal (CHUM);London Health Sciences Centre;University of Calgary;McGill University;Laval University;Merck Frosst Canada Ltd. | Completed | 18 Years | N/A | Both | 56 | Phase 4 | Canada |
| 2 | NCT01812551 (ClinicalTrials.gov) | October 2002 | 14/3/2013 | Treatment of Low Bone Density in Cystic Fibrosis. | Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial. | Osteoporosis;Cystic Fibrosis | Drug: Alendronate;Drug: Placebo | Istituto Auxologico Italiano | Fondazione Telethon | Completed | 5 Years | 30 Years | Both | 171 | Phase 3 | Holy See (Vatican City State);Italy |
| 3 | NCT00004489 (ClinicalTrials.gov) | October 1998 | 18/10/1999 | Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis | Osteoporosis;Cystic Fibrosis | Drug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferol | University of North Carolina | NULL | Completed | 18 Years | 45 Years | Both | 60 | N/A | United States |