Aclasta (DrugBank: -)
3 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 3 |
| 271 | Ankylosing spondylitis | 1 |
| 274 | Osteogenesis Imperfecta | 2 |
| 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 | NCT01166178 (ClinicalTrials.gov) | October 2010 | 19/7/2010 | Zoledronic Acid in MS-patients With Osteoporosis | A 1-year, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Zoledronic Acid 5 mg (Aclasta®) on Bone Mineral Density in Patients With Multiple Sclerosis Followed by a 1-year Open-label Treatment Phase | Osteoporosis;Multiple Sclerosis | Drug: Zoledronic Acid;Drug: Placebo;Dietary Supplement: Calcium and Vitamin D combination | Novartis | NULL | Terminated | 18 Years | 75 Years | All | 29 | Phase 3 | Germany |
| 2 | EUCTR2009-011888-37-DE (EUCTR) | 23/07/2010 | 26/03/2010 | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | A 1-year, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of zoledronic acid 5 mg (Aclasta®) on bone mineral density in patients with multiple sclerosis followed by a 1-year open-label treatment phase - EXALT | osteoporosis in patients with multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10049088;Term: Osteopenia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10031282;Term: Osteoporosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Aclasta 5 mg Infusionslösung Product Name: Aclasta Product Code: ZOL446H Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase - | Germany | |||
| 3 | EUCTR2008-005304-93-GB (EUCTR) | 13/02/2009 | 12/12/2008 | A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis | A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis | Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10065687;Term: Bone loss | Trade Name: Aclasta 5mg solution for infusion Product Name: Aclasta Product Code: ZOL446H | North Bristol Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom |
| 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 | EUCTR2007-000087-25-GB (EUCTR) | 22/10/2007 | 27/07/2007 | An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07 | An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07 | Ankylosing Spondylitis MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: Aclasta | Cambridge University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom |
| 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 | EUCTR2011-000745-21-BE (EUCTR) | 10/12/2012 | 18/09/2012 | An international, multicenter, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta | An international, multicenter, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta - SHC - INFOI | Children suffering from severe Osteogenesis Imperfecta MedDRA version: 14.1;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: ACLASTA Product Name: zoledronic acid INN or Proposed INN: RITUXIMAB | Schriners Hospitals for Children | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | United States;Canada;Belgium | |||
| 2 | EUCTR2011-002811-27-DK (EUCTR) | 07/11/2011 | 04/11/2011 | The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta | The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatment | Osteogenesis imperfecta;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Forsteo Product Code: H05AA02 Trade Name: Aclasta | Bente Langdahl, consultant, ass. professor, PhD, DMSc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Denmark |