[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485018":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":26,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Zoledronic Acid loaded bone cement","EXPERIMENTAL","4mg zoledronic acid-loaded gentamicin bone cement (PMMA)",[13],"Procedure: 4mg ZOL loaded gentamicin PMMA",{"label":15,"type":16,"description":17,"interventionNames":18},"conventional gentamicin bone cement","ACTIVE_COMPARATOR","gentamicin bone cement (PMMA)",[19],"Procedure: gentamicin PMMA",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","4mg ZOL loaded gentamicin PMMA","During surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"gentamicin PMMA","During surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Meng Liu, MD","CONTACT","13515711791","liumeng80@163.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Keyi Wang, MS","17398046579","wky82630965@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Second Affiliated Hospital of Zhejiang University","RECRUITING","Hangzhou","311200","China","CN",{"type":50,"coordinates":51},"Point",[52,53],120.16142,30.29365,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":35,"phoneExt":26,"email":36},"Meng Liu",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100485018","phase-2-zoledronic-acid-loaded-bone-cement-as-a-local-adjuvant-therapy-for-giant-cell-bone-tumor-after-intralesional-curettage-100485018",false,"NCT05595603","Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage","Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.","Inclusion Criteria:\n\n* patients with primary resectable GCT of bone\n* lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal\n* no previous systemic bisphosphonate or denosumab therapy\n* with expected longer than 18 months of survival time\n* sign the informed consent form\n\nExclusion Criteria:\n\n* patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its \"unresectable\" nature.\n* conduct unexpected surgery at other center\n* the primary goal for surgery is revision\n* patient conduct en-bloc\u002Fwide resection instead of curettage surgery\n* patient can not conduct self-assessment during follow up\n* difficulty in complete postoperative follow-up\n* previous use of bisphosphonate\u002FZOL or denosumab drug\n* patients have participated in similar research projects\n* refused to sign informed consent","ALL",{"count":69,"type":70},153,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).",[76],"Giant Cell Tumor of Bone",[78],"Zoledronic Acid, intralesional curettage","2023-03-13",{"date":81,"type":82},"2023-03-15","ACTUAL",{"date":84,"type":70},"2023-03",{"date":86,"type":70},"2026-12-01",{"name":5,"class":6},1]