[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100308490":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":37,"studyPopulation":27,"armGroups":38,"interventions":49,"overallOfficials":27,"centralContacts":57,"locations":67,"responsibleParty":298,"collaborators":301,"id":327,"slug":27,"hasResults":328,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":27,"eligibilityCriteria":332,"healthyVolunteers":333,"sex":334,"minAge":335,"maxAge":27,"enrollmentInfo":336,"targetDuration":27,"studyType":339,"phases":340,"briefSummary":342,"conditions":343,"keywords":27,"overallStatus":70,"whyStopped":27,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":354},{"fullName":5,"class":6},"St. Louis University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"The endpoint for patient participation will be local recurrence","Local recurrence of giant cell tumor of bone","Followed for 2 years postoperatively for study end points",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"MSTS Score","The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research",{"measure":18,"description":19,"timeFrame":20},"Surgical site infection","The surgical site will be assessed for a surgical site infection (SSI) as defined by CDC guidelines after surgery and during scheduled follow-up as outlined in time frame below.","Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.",{"measure":22,"description":23,"timeFrame":20},"Wound healing","The surgical site will be assessed after surgery and during scheduled follow-up as outlined in time frame below for wound healing issues\u002Fconcerns.",{"measure":25,"description":26,"timeFrame":12},"Potential bisphosphonate complications related to systemic administration","Patients will be followed for atypical femur fractures and avascular necrosis (AVN) of jaw",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","Randomized controlled trial","TREATMENT",{"masking":34,"maskingDescription":27,"whoMasked":35},"SINGLE",[36],"PARTICIPANT","The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.",[39,43],{"label":40,"type":41,"description":42,"interventionNames":27},"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.",{"label":44,"type":45,"description":46,"interventionNames":47},"Bisphosphonate group","EXPERIMENTAL","In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.",[48],"Drug: Zoledronic Acid",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"DRUG","Zoledronic Acid","4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement",[44],[56],"zoledronate",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":27,"email":62},"Allison Gruender, RN","CONTACT","314-617-3406","allison.gruender@health.slu.edu",{"name":64,"role":60,"phone":65,"phoneExt":27,"email":66},"Marsha Steffen, RN","314-617-3410","marsha.steffen@slucare.ssmhealth.com",[68,88,106,122,133,149,165,177,188,204,214,230,246,262,272,284],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University of California - Los Angeles","RECRUITING","Los Angeles","California","90404","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-118.24368,34.05223,{"lat":80,"lon":79},[83,85],{"name":84,"role":60,"phone":27,"phoneExt":27,"email":27},"Alexander Christ",{"name":86,"role":87,"phone":27,"phoneExt":27,"email":27},"Alexander Christ, MD","PRINCIPAL_INVESTIGATOR",{"facility":89,"status":70,"city":90,"state":91,"zip":92,"country":74,"countryCode":75,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Indiana University","Indianapolis","Indiana","46202",{"type":77,"coordinates":94},[95,96],-86.15804,39.76838,{"lat":96,"lon":95},[99,102,104],{"name":100,"role":60,"phone":27,"phoneExt":27,"email":101},"Charalampos Lyssikatos","clyssika@iu.edu",{"name":103,"role":87,"phone":27,"phoneExt":27,"email":27},"L.Daniel Wurtz, MD",{"name":105,"role":87,"phone":27,"phoneExt":27,"email":27},"Christopher Collier, MD",{"facility":107,"status":70,"city":108,"state":109,"zip":110,"country":74,"countryCode":75,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"University of Iowa","Iowa City","Iowa","52242",{"type":77,"coordinates":112},[113,114],-91.53017,41.66113,{"lat":114,"lon":113},[117,120],{"name":118,"role":60,"phone":27,"phoneExt":27,"email":119},"Abigail Grothe","abigail-grothe@uiowa.edu",{"name":121,"role":87,"phone":27,"phoneExt":27,"email":27},"Benjamin Miller, MD",{"facility":123,"status":124,"city":125,"state":126,"zip":127,"country":74,"countryCode":75,"cosmosGeoPoint":128,"geoPoint":132,"contacts":27},"University of Kansas","COMPLETED","Overland Park","Kansas","66211",{"type":77,"coordinates":129},[130,131],-94.67079,38.98223,{"lat":131,"lon":130},{"facility":134,"status":70,"city":135,"state":136,"zip":137,"country":74,"countryCode":75,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Johns Hopkins University Hospital","Baltimore","Maryland","21287",{"type":77,"coordinates":139},[140,141],-76.61219,39.29038,{"lat":141,"lon":140},[144,147],{"name":145,"role":60,"phone":27,"phoneExt":27,"email":146},"Vaishali Laljani","vparikh2@jhmi.edu",{"name":148,"role":87,"phone":27,"phoneExt":27,"email":27},"Adam Levin, MD",{"facility":150,"status":70,"city":151,"state":152,"zip":153,"country":74,"countryCode":75,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":77,"coordinates":155},[156,157],-71.05977,42.35843,{"lat":157,"lon":156},[160,163],{"name":161,"role":60,"phone":27,"phoneExt":27,"email":162},"Emily Berner","EABERNER@mgh.harvard.edu",{"name":164,"role":87,"phone":27,"phoneExt":27,"email":27},"Santiago Lozano Calderon, MD",{"facility":166,"status":70,"city":151,"state":152,"zip":167,"country":74,"countryCode":75,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"Boston Children's Hospital","02115",{"type":77,"coordinates":169},[156,157],{"lat":157,"lon":156},[172,175],{"name":173,"role":60,"phone":27,"phoneExt":27,"email":174},"Saurav Pandey","Saurav.Pandey@childrens.harvard.edu",{"name":176,"role":87,"phone":27,"phoneExt":27,"email":27},"Megan Anderson, MD",{"facility":178,"status":70,"city":151,"state":152,"zip":179,"country":74,"countryCode":75,"cosmosGeoPoint":180,"geoPoint":182,"contacts":183},"Beth Israel Deaconess Medical Center","02215",{"type":77,"coordinates":181},[156,157],{"lat":157,"lon":156},[184,187],{"name":185,"role":60,"phone":27,"phoneExt":27,"email":186},"Katiri Wagner","kwagner@bidmc.harvard.edu",{"name":176,"role":87,"phone":27,"phoneExt":27,"email":27},{"facility":189,"status":70,"city":190,"state":191,"zip":192,"country":74,"countryCode":75,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Saint Louis University","St Louis","Missouri","63110",{"type":77,"coordinates":194},[195,196],-90.19789,38.62727,{"lat":196,"lon":195},[199,202],{"name":200,"role":60,"phone":65,"phoneExt":27,"email":201},"David Greenberg, MD","david.greenberg@slucare.ssmhealth.com",{"name":59,"role":60,"phone":203,"phoneExt":27,"email":62},"(314) 617-3406",{"facility":205,"status":124,"city":206,"state":207,"zip":208,"country":74,"countryCode":75,"cosmosGeoPoint":209,"geoPoint":213,"contacts":27},"Wake Forest University","Winston-Salem","North Carolina","27157",{"type":77,"coordinates":210},[211,212],-80.24422,36.09986,{"lat":212,"lon":211},{"facility":215,"status":70,"city":216,"state":217,"zip":218,"country":74,"countryCode":75,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":77,"coordinates":220},[221,222],-81.69541,41.4995,{"lat":222,"lon":221},[225,228],{"name":226,"role":60,"phone":27,"phoneExt":27,"email":227},"Heather Keaney, MPH","keaneyh@ccf.org",{"name":229,"role":87,"phone":27,"phoneExt":27,"email":27},"Lukas Nystrom, MD",{"facility":231,"status":70,"city":232,"state":233,"zip":234,"country":74,"countryCode":75,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"University of Oklahoma","Oklahoma City","Oklahoma","73104",{"type":77,"coordinates":236},[237,238],-97.51643,35.46756,{"lat":238,"lon":237},[241,244],{"name":242,"role":60,"phone":27,"phoneExt":27,"email":243},"Kathy Edge","Kathy-edge@ouhsc.edu",{"name":245,"role":87,"phone":27,"phoneExt":27,"email":27},"Jeremy White, MD",{"facility":247,"status":70,"city":248,"state":249,"zip":250,"country":74,"countryCode":75,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Allegheny-Singer Research Institute","Pittsburgh","Pennsylvania","15212",{"type":77,"coordinates":252},[253,254],-79.99589,40.44062,{"lat":254,"lon":253},[257,260],{"name":258,"role":60,"phone":27,"phoneExt":27,"email":259},"Myles Forsyth","myles.forsyth@ahn.org",{"name":261,"role":87,"phone":27,"phoneExt":27,"email":27},"Lisa Ercolano, MD",{"facility":263,"status":124,"city":264,"state":265,"zip":266,"country":74,"countryCode":75,"cosmosGeoPoint":267,"geoPoint":271,"contacts":27},"University of Washington","Seattle","Washington","98195",{"type":77,"coordinates":268},[269,270],-122.33207,47.60621,{"lat":270,"lon":269},{"facility":273,"status":124,"city":274,"state":275,"zip":276,"country":277,"countryCode":278,"cosmosGeoPoint":279,"geoPoint":283,"contacts":27},"McGill University Health Centre","Montreal","Quebec","H3G 1A4","Canada","CA",{"type":77,"coordinates":280},[281,282],-73.58781,45.50884,{"lat":282,"lon":281},{"facility":285,"status":70,"city":286,"state":27,"zip":287,"country":288,"countryCode":289,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"All India Institute of Medical Science","New Delhi","110029","India","IN",{"type":77,"coordinates":291},[292,293],77.2148,28.62137,{"lat":293,"lon":292},[296],{"name":297,"role":60,"phone":27,"phoneExt":27,"email":27},"Shah Alam Khan",{"type":87,"investigatorFullName":299,"investigatorTitle":300,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"David D. Greenberg, MD; Professor","Professor Orthopaedic Surgery Saint Louis University",[302,304,306,307,309,311,313,314,315,316,317,318,319,321,322,324,325],{"name":303,"class":6},"Orthopedic Research and Education Foundation",{"name":305,"class":6},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"name":107,"class":6},{"name":308,"class":6},"Johns Hopkins University",{"name":310,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":312,"class":6},"The Cleveland Clinic",{"name":205,"class":6},{"name":123,"class":6},{"name":89,"class":6},{"name":231,"class":6},{"name":178,"class":6},{"name":166,"class":6},{"name":320,"class":6},"American Academy of Orthopaedic Surgeons",{"name":150,"class":6},{"name":323,"class":6},"All India Institute of Medical Sciences",{"name":263,"class":6},{"name":326,"class":6},"University of California","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":337,"type":338},120,"ESTIMATED","INTERVENTIONAL",[341],"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.",[344],"Giant Cell Tumor of Bone","2026-04-17",{"date":347,"type":348},"2026-04-22","ACTUAL",{"date":350,"type":348},"2018-05-03",{"date":352,"type":338},"2028-01",{"name":5,"class":6},16]