[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621797":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":49,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Zoledronate","EXPERIMENTAL","Zoledronate dose will be given intravenously over 1 hour using standard infusion equipment. Patients will receive a dose of 0.025 mg\u002Fkg. Zoledronate will be infused in the inpatient setting to facilitate proper observation and data collection.",[13],"Drug: Zoledronate",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Zoledronate is in the class of drugs entitled bisphosphonates which act to inhibit bone resorption by inhibiting osteoclast activity therefore reducing bone turnover.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Jessi Anderson","CONTACT","513-803-0177","Jessica.Anderson@cchmc.org",{"name":27,"role":23,"phone":19,"phoneExt":19,"email":28},"Brady Landon","Brady.Landon@cchmc.org",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-84.51439,39.12711,{"lat":42,"lon":41},[45,46],{"name":22,"role":23,"phone":19,"phoneExt":19,"email":25},{"name":47,"role":48,"phone":19,"phoneExt":19,"email":19},"Jonathan Howell, MD","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100621797","phase-1-zoledronate-to-prevent-bone-health-complications-in-pediatric-hematopoietic-stem-cell-transplant-survivors-100621797",false,"NCT07375290","Zoledronate to Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors","Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors","Inclusion Criteria:\n\n* Patients ≥5 and ≤18 years old who are preparing for HSCT with a height-for-age corrected DXA Z-score of \\\u003C-2.0 and admitted to a CCHMC inpatient unit.\n* Patients ≥5 and ≤18 years old recovering from HSCT and who have developed de novo acute or chronic GVHD and are admitted to a CCHMC inpatient unit.\n\nExclusion Criteria:\n\n* Age \\\u003C5 years and \\>18 years\n* Patients with Fanconi anemia or other radiation-sensitive syndromes with increased malignancy risk\n* history of prior bisphosphonate use\n* low 25-OH vitamin D levels (\\\u003C20 ng\u002FmL)\n* active febrile illness\n* uncontrolled infection\n* Elevated creatinine at the time of enrollment, history or renal failure, or documented low glomerular filtration rate (GFR≤90)\n* Active bone disease including history of abnormal PTH level for any reason, active bone fracture\u002Fhealing, or primary disorder of bone development or metabolism.\n* Women who are pregnant or breast feeding.","ALL","5 Years","18 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","The purpose of this pilot study is to investigate the safety and preliminarily assess efficacy of early intervention with zoledronate in high risk pediatric hematopoietic stem cell transplantation (HSCT) patients to prevent the development of bone disease and fractures and reduce potential pain and suffering.",[69],"Hematopoietic Stem Cell Transplantation","2026-01-21",{"date":72,"type":73},"2026-01-29","ACTUAL",{"date":75,"type":63},"2026-02",{"date":77,"type":63},"2028-11",{"name":5,"class":6},1]