[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100083634":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":15,"responsibleParty":27,"collaborators":7,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":7,"eligibilityCriteria":34,"healthyVolunteers":31,"sex":35,"minAge":36,"maxAge":7,"enrollmentInfo":37,"targetDuration":7,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":45,"overallStatus":49,"whyStopped":7,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":7,"leadSponsor":56,"locationsCount":58},{"fullName":5,"class":6},"Novartis","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Zoledronic Acid",[13],{"name":5,"affiliation":5,"role":14},"STUDY_CHAIR",[16],{"facility":17,"status":7,"city":18,"state":7,"zip":7,"country":19,"countryCode":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":7},"Novartis Investigative Site","Athens","Greece","GR",{"type":22,"coordinates":23},"Point",[24,25],23.72784,37.98376,{"lat":25,"lon":24},{"type":28,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100083634","phase-4-evaluation-of-efficacy-of-zoledronic-acid-in-patients-with-haemoglobin-syndromes-thalassemia-and-sicle-cell-anaemia-and-risk-of-skeletal-events-100083634",false,"NCT00346242","Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events","Inclusion Criteria:\n\n* Patients with thalassaemia or sickle cell anaemia and bone density, z-scores \\\u003C -1.5, in at least one of the examined sites\n* Normal renal function. Urea and creatinine should not exceed \\> 2-fold the upper limit of normal (\\\u003C 2 x ULN).\n\nExclusion Criteria:\n\n\\-\n\nOther protocol-defined inclusion \u002F exclusion criteria may apply.","ALL","18 Years",{"count":38,"type":7},60,"INTERVENTIONAL",[41],"PHASE4","The evaluation of efficacy is performed by laboratory monitoring of bone density and resorption markers and clinical monitoring of bone density improvement. This is a prospective, randomized, parallel group, single blind study of one year treatment with zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3 months and to placebo every 3 months in patients with hemoglobin syndromes and risk of skeletal complications.",[44],"Thalassemia",[46,47,48],"thalassemia","zoledronic acid","skeletal events","COMPLETED","2012-04-29",{"date":52,"type":53},"2012-05-01","ESTIMATED",{"date":55,"type":7},"2004-03",{"name":57,"class":6},"Novartis Pharmaceuticals",1]