[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100308490":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":27,"locations":37,"responsibleParty":268,"collaborators":271,"id":297,"slug":298,"hasResults":299,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":12,"eligibilityCriteria":303,"healthyVolunteers":304,"sex":305,"minAge":306,"maxAge":12,"enrollmentInfo":307,"targetDuration":12,"studyType":310,"phases":311,"briefSummary":313,"conditions":314,"keywords":12,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},{"fullName":5,"class":6},"St. Louis University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Bisphosphonate group","EXPERIMENTAL","In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.",[18],"Drug: Zoledronic Acid",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Zoledronic Acid","4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement",[14],[26],"zoledronate",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"Allison Gruender, RN","CONTACT","314-617-3406","allison.gruender@health.slu.edu",{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},"Marsha Steffen, RN","314-617-3410","marsha.steffen@slucare.ssmhealth.com",[38,58,76,92,103,119,135,147,158,174,184,200,216,232,242,254],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of California - Los Angeles","RECRUITING","Los Angeles","California","90404","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.24368,34.05223,{"lat":50,"lon":49},[53,55],{"name":54,"role":30,"phone":12,"phoneExt":12,"email":12},"Alexander Christ",{"name":56,"role":57,"phone":12,"phoneExt":12,"email":12},"Alexander Christ, MD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":40,"city":60,"state":61,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Indiana University","Indianapolis","Indiana","46202",{"type":47,"coordinates":64},[65,66],-86.15804,39.76838,{"lat":66,"lon":65},[69,72,74],{"name":70,"role":30,"phone":12,"phoneExt":12,"email":71},"Charalampos 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Park","Kansas","66211",{"type":47,"coordinates":99},[100,101],-94.67079,38.98223,{"lat":101,"lon":100},{"facility":104,"status":40,"city":105,"state":106,"zip":107,"country":44,"countryCode":45,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Johns Hopkins University Hospital","Baltimore","Maryland","21287",{"type":47,"coordinates":109},[110,111],-76.61219,39.29038,{"lat":111,"lon":110},[114,117],{"name":115,"role":30,"phone":12,"phoneExt":12,"email":116},"Vaishali Laljani","vparikh2@jhmi.edu",{"name":118,"role":57,"phone":12,"phoneExt":12,"email":12},"Adam Levin, MD",{"facility":120,"status":40,"city":121,"state":122,"zip":123,"country":44,"countryCode":45,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":47,"coordinates":125},[126,127],-71.05977,42.35843,{"lat":127,"lon":126},[130,133],{"name":131,"role":30,"phone":12,"phoneExt":12,"email":132},"Emily Berner","EABERNER@mgh.harvard.edu",{"name":134,"role":57,"phone":12,"phoneExt":12,"email":12},"Santiago Lozano Calderon, MD",{"facility":136,"status":40,"city":121,"state":122,"zip":137,"country":44,"countryCode":45,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"Boston Children's Hospital","02115",{"type":47,"coordinates":139},[126,127],{"lat":127,"lon":126},[142,145],{"name":143,"role":30,"phone":12,"phoneExt":12,"email":144},"Saurav Pandey","Saurav.Pandey@childrens.harvard.edu",{"name":146,"role":57,"phone":12,"phoneExt":12,"email":12},"Megan Anderson, MD",{"facility":148,"status":40,"city":121,"state":122,"zip":149,"country":44,"countryCode":45,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"Beth Israel Deaconess Medical Center","02215",{"type":47,"coordinates":151},[126,127],{"lat":127,"lon":126},[154,157],{"name":155,"role":30,"phone":12,"phoneExt":12,"email":156},"Katiri Wagner","kwagner@bidmc.harvard.edu",{"name":146,"role":57,"phone":12,"phoneExt":12,"email":12},{"facility":159,"status":40,"city":160,"state":161,"zip":162,"country":44,"countryCode":45,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Saint Louis University","St Louis","Missouri","63110",{"type":47,"coordinates":164},[165,166],-90.19789,38.62727,{"lat":166,"lon":165},[169,172],{"name":170,"role":30,"phone":35,"phoneExt":12,"email":171},"David Greenberg, MD","david.greenberg@slucare.ssmhealth.com",{"name":29,"role":30,"phone":173,"phoneExt":12,"email":32},"(314) 617-3406",{"facility":175,"status":94,"city":176,"state":177,"zip":178,"country":44,"countryCode":45,"cosmosGeoPoint":179,"geoPoint":183,"contacts":12},"Wake Forest University","Winston-Salem","North Carolina","27157",{"type":47,"coordinates":180},[181,182],-80.24422,36.09986,{"lat":182,"lon":181},{"facility":185,"status":40,"city":186,"state":187,"zip":188,"country":44,"countryCode":45,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":47,"coordinates":190},[191,192],-81.69541,41.4995,{"lat":192,"lon":191},[195,198],{"name":196,"role":30,"phone":12,"phoneExt":12,"email":197},"Heather Keaney, MPH","keaneyh@ccf.org",{"name":199,"role":57,"phone":12,"phoneExt":12,"email":12},"Lukas Nystrom, MD",{"facility":201,"status":40,"city":202,"state":203,"zip":204,"country":44,"countryCode":45,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"University of Oklahoma","Oklahoma City","Oklahoma","73104",{"type":47,"coordinates":206},[207,208],-97.51643,35.46756,{"lat":208,"lon":207},[211,214],{"name":212,"role":30,"phone":12,"phoneExt":12,"email":213},"Kathy Edge","Kathy-edge@ouhsc.edu",{"name":215,"role":57,"phone":12,"phoneExt":12,"email":12},"Jeremy White, MD",{"facility":217,"status":40,"city":218,"state":219,"zip":220,"country":44,"countryCode":45,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Allegheny-Singer Research Institute","Pittsburgh","Pennsylvania","15212",{"type":47,"coordinates":222},[223,224],-79.99589,40.44062,{"lat":224,"lon":223},[227,230],{"name":228,"role":30,"phone":12,"phoneExt":12,"email":229},"Myles Forsyth","myles.forsyth@ahn.org",{"name":231,"role":57,"phone":12,"phoneExt":12,"email":12},"Lisa Ercolano, MD",{"facility":233,"status":94,"city":234,"state":235,"zip":236,"country":44,"countryCode":45,"cosmosGeoPoint":237,"geoPoint":241,"contacts":12},"University of Washington","Seattle","Washington","98195",{"type":47,"coordinates":238},[239,240],-122.33207,47.60621,{"lat":240,"lon":239},{"facility":243,"status":94,"city":244,"state":245,"zip":246,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":12},"McGill University Health Centre","Montreal","Quebec","H3G 1A4","Canada","CA",{"type":47,"coordinates":250},[251,252],-73.58781,45.50884,{"lat":252,"lon":251},{"facility":255,"status":40,"city":256,"state":12,"zip":257,"country":258,"countryCode":259,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"All India Institute of Medical Science","New Delhi","110029","India","IN",{"type":47,"coordinates":261},[262,263],77.2148,28.62137,{"lat":263,"lon":262},[266],{"name":267,"role":30,"phone":12,"phoneExt":12,"email":12},"Shah Alam Khan",{"type":57,"investigatorFullName":269,"investigatorTitle":270,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"David D. Greenberg, MD; Professor","Professor Orthopaedic Surgery Saint Louis University",[272,274,276,277,279,281,283,284,285,286,287,288,289,291,292,294,295],{"name":273,"class":6},"Orthopedic Research and Education Foundation",{"name":275,"class":6},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"name":77,"class":6},{"name":278,"class":6},"Johns Hopkins University",{"name":280,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":282,"class":6},"The Cleveland Clinic",{"name":175,"class":6},{"name":93,"class":6},{"name":59,"class":6},{"name":201,"class":6},{"name":148,"class":6},{"name":136,"class":6},{"name":290,"class":6},"American Academy of Orthopaedic Surgeons",{"name":120,"class":6},{"name":293,"class":6},"All India Institute of Medical Sciences",{"name":233,"class":6},{"name":296,"class":6},"University of California","100308490","phase-3-local-bisphosphonate-effect-on-recurrence-rate-in-extremity-giant-cell-tumor-of-bone-100308490",false,"NCT03295981","Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone","Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Primary benign GCT of bone\n* Lesion located in an extremity\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\nExclusion Criteria:\n\n* Recurrent GCT of bone\n* Non-extremity location\n* Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component\n* Children and pregnancy\n* Previous systemic bisphosphonate or denosumab therapy",true,"ALL","18 Years",{"count":308,"type":309},120,"ESTIMATED","INTERVENTIONAL",[312],"PHASE3","The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.",[315],"Giant Cell Tumor of Bone","2026-04-17",{"date":318,"type":319},"2026-04-22","ACTUAL",{"date":321,"type":319},"2018-05-03",{"date":323,"type":309},"2028-01",{"name":5,"class":6},16]