[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574703":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":42,"locations":52,"responsibleParty":116,"collaborators":119,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":18,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":18,"enrollmentInfo":132,"targetDuration":18,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":72,"whyStopped":18,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Zoledronic acid","EXPERIMENTAL","Patients with T score from -1 to -2.4 will be treated with 1 dose of 5 mg of Zoledronic acid within a month of ART intiation.",[13],"Drug: Zoledronic Acid 5 mg\u002FBag 100 ml Inj",{"label":15,"type":16,"description":17,"interventionNames":18},"Follow up-comparator","NO_INTERVENTION","Patients with T score from -1 to -2.4 that will be followed without intervention",null,{"label":20,"type":16,"description":21,"interventionNames":18},"mildly osteopenic patients","patients with T score more than -1 will be followed only after antiviral treatment initiation- P1NP and CTX levels and DXA up to 4 years",{"label":23,"type":16,"description":24,"interventionNames":18},"Osteoporotic patients","patients with T score less than -2.5 will be treated according to standard of care with oral biphosphonates, and will be followed after antiviral treatment intiation- P1NP + CTX and DXA up to 4 years",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":18},"DRUG","Zoledronic Acid 5 mg\u002FBag 100 ml Inj","Zolendric acid will be provided to HIV naïve patients with documented osteopnia",[9],[32,36,39],{"name":33,"affiliation":34,"role":35},"Hila Elinav, Doctor","Hadassah University Medical center","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Eynat Kedem, Doctor","Rambam Health Care Campus",{"name":40,"affiliation":41,"role":35},"Itzchak Levy, Proffesor","Sheba Medical Center",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":18,"email":47},"Hila Doctor Elinav, Doctor","CONTACT","+972587874340","hilaelinav@gmail.com",{"name":49,"role":45,"phone":50,"phoneExt":18,"email":51},"Auryan Szalat, Doctor","+9725078743735","auryans@hadassah.org.il",[53,70,103],{"facility":54,"status":55,"city":56,"state":18,"zip":18,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Rambam Medical Center","NOT_YET_RECRUITING","Haifa","Israel","IL",{"type":60,"coordinates":61},"Point",[62,63],34.99928,32.81303,{"lat":63,"lon":62},[66,69],{"name":37,"role":45,"phone":67,"phoneExt":18,"email":68},"972536283187","e_kedem@rambam.health.gov.il",{"name":37,"role":35,"phone":18,"phoneExt":18,"email":18},{"facility":71,"status":72,"city":73,"state":18,"zip":74,"country":57,"countryCode":58,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hadassah Hebrew University Medical Center","RECRUITING","Jerusalem","9112001",{"type":60,"coordinates":76},[77,78],35.21633,31.76904,{"lat":78,"lon":77},[81,82,86,87,89,91,93,95,97,99,101],{"name":33,"role":45,"phone":46,"phoneExt":18,"email":47},{"name":83,"role":45,"phone":84,"phoneExt":18,"email":85},"Daniella Iluz","972504048807","danielaI@hadassah.org.il",{"name":33,"role":35,"phone":18,"phoneExt":18,"email":18},{"name":49,"role":88,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":90,"role":88,"phone":18,"phoneExt":18,"email":18},"Shalev Lussheimer, Doctor",{"name":92,"role":88,"phone":18,"phoneExt":18,"email":18},"Keren Olshtain-pops, Doctor",{"name":94,"role":88,"phone":18,"phoneExt":18,"email":18},"Sarah Israel, Doctor",{"name":96,"role":88,"phone":18,"phoneExt":18,"email":18},"'Yonatan Oster, Doctor",{"name":98,"role":88,"phone":18,"phoneExt":18,"email":18},"Maya Korem, Doctor",{"name":100,"role":88,"phone":18,"phoneExt":18,"email":18},"Daniel Grupel, Doctor",{"name":102,"role":88,"phone":18,"phoneExt":18,"email":18},"Efrat Orenbuch-Harroch, Doctor",{"facility":41,"status":55,"city":104,"state":18,"zip":18,"country":57,"countryCode":58,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Ramat Gan",{"type":60,"coordinates":106},[107,108],34.81065,32.08227,{"lat":108,"lon":107},[111,115],{"name":112,"role":45,"phone":113,"phoneExt":18,"email":114},"Itzchak Levy, Preoffesor","972526667525","itsik.levi@sheba.health.gov.il",{"name":40,"role":88,"phone":18,"phoneExt":18,"email":18},{"type":35,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Hila Elinav","Professor",[120,122],{"name":41,"class":121},"OTHER_GOV",{"name":38,"class":6},"100574703","phase-4-zoledronic-acid-for-the-prevention-of-tdf-sparing-art-induced-bone-mass-density-loss-in-treatment-naive-hiv-positive-individuals-100574703",false,"NCT06762730","Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals","A Single Dose Intravenous Administration of Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals - a Prospective, Multicenter, Open-label, Randomized Control Trial","Inclusion Criteria:\n\n* Adults over age of 18 years old of any gender, social, religious or racial background.\n* Confirmed positive result for HIV infection.\n\nExclusion Criteria:\n\nPatients who received previous pharmacological agents for the prevention of HIV infection.\n\n* Women who are pregnant, lactating or those who plan to become pregnant within the trial timeframe.\n* Past history of severe drug-induced reaction (including atypical femur fractures or osteonecrosis of the jaw) or documented hypersensitivity to a bisphosphanate agent.\n* Patients with untreated hypocalcemia at screening.\n* Severe dental status","ALL","18 Years",{"count":133,"type":134},110,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","The goal of this clinical trial is to learn if zolendric acid can prevent the anticipated deterioration of bone mass after antiviral treatment initiation for people that were recently diagnosed with HIV.\n\nThe main questions it aims to answer are:\n\n1. Is bone mass deterioration is significant even with the new medication currently used to treat HIV?\n2. Can one dose of Zolendric acid protect from deterioration of bone mass.\n\nResearchers will compare one dose of zolendric acid to follow-up only\n\nParticipant will:\n\n1. Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation\n2. Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months\n3. Half of the patients with moderate reduction in bone mass will be treated with one dose of zolendric acid in the clinical trial, the other participants will be followed without intervention.\n4. Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.",[140,141],"HIV Infected Individuals","Osteopenia",[141,143,144],"zoledronic acid","HIV naïve","2025-09-13",{"date":147,"type":148},"2025-09-18","ACTUAL",{"date":150,"type":148},"2024-12-09",{"date":152,"type":134},"2032-12-01",{"name":5,"class":6},3]