[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100085844":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":23,"responsibleParty":29,"collaborators":11,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":11,"leadSponsor":62,"locationsCount":63},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"zoledronate","EXPERIMENTAL",null,[13],"Drug: Zoledronic acid",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":11},"DRUG","Zoledronic acid",[9],[20],{"name":21,"affiliation":21,"role":22},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[24],{"facility":25,"status":11,"city":26,"state":11,"zip":11,"country":27,"countryCode":28,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Novartis Investigative Site","Monpellier","France","FR",{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":30,"oldOrganization":21},"External Affairs","100085844","phase-3-efficacy-and-safety-of-zoledronic-acid-in-the-treatment-of-bone-metastases-related-pain-in-patients-with-prostate-cancer-100085844",false,"NCT00375648","Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer","Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer","TRAPEZE","Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the prostate\n* Bone-scan documented metastases\n* Age \\> 18 years\n* Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion\n* Life expectancy \\> 3 months\n* Written informed consent\n\nExclusion Criteria:\n\n* New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks\n* Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry\n* Bisphosphonate therapy within 8 weeks before study entry\n* Abnormal renal function (serum creatinine \\> 2 x the upper normal limit or creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Corrected serum calcium \\> 3 mmol\u002FL or \\\u003C 2 mmol\u002FL\n* Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug\n* Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain\n* Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)\n\nOther protocol-defined exclusion criteria may apply.","MALE","18 Years",{"count":42,"type":43},61,"ACTUAL","INTERVENTIONAL",[46],"PHASE3","This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.",[49],"Pain",[51,52,53,17,54,55],"Prostate","Cancer","Bone metastases","Bone metastases-related pain","Prostate cancer","COMPLETED","2017-05-31",{"date":59,"type":43},"2017-06-02",{"date":61,"type":11},"2005-06",{"name":21,"class":6},1]