[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551260":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":25,"overallOfficials":13,"centralContacts":31,"locations":38,"responsibleParty":55,"collaborators":13,"id":58,"slug":13,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":13,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":13,"enrollmentInfo":66,"targetDuration":13,"studyType":69,"phases":13,"briefSummary":70,"conditions":71,"keywords":13,"overallStatus":41,"whyStopped":13,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Catholic University of the Sacred Heart","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Medication Related OsteoNecrosis of the Jaws","Incidence of Medication Related OsteoNecrosis of the Jaws","Five years after the beginning of AR therapy",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. In particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients.\n\nSpecifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). In the United States, approximately 400,000 individuals suffer from bone metastasis. The most frequent skeletal complications in patients with bone metastases (referred to as SRE - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.The introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient.\n\nThe objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.","Patients starting an antiresorptive drug",[20],{"label":21,"type":13,"description":22,"interventionNames":23},"Antiresorptive Drugs","Patients treated by means of Antiresorptive drugs due to either bone metastasis or metabolic diseases",[24],"Procedure: Dental management",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":13},"PROCEDURE","Dental management","The oral conditions of the included patients will be evaluated at baseline. When indicated, dental extractions will be performed before the beginning of Antiresorptive Therapy. Patients will then receive a six-months intervals follow-up, during which primary and secondary prevention of dental diseases will be performed.",[21],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Carlo Lajolo, Prof.","CONTACT","3356078354","+39","carlo.lajolo@unicatt.it",[39],{"facility":40,"status":41,"city":42,"state":13,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Cosimo Rupe","RECRUITING","Roma","00168","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],11.10642,44.99364,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":13,"phoneExt":13,"email":13},"Carlo Lajolo",{"type":56,"investigatorFullName":54,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Associate Professor","100551260",false,"NCT06457776","Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs","Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study","Inclusion Criteria:\n\n* Patients with specific prescription to initiate therapy with antiresorptive drugs\n\nExclusion Criteria:\n\n* Previous Head and Neck Radiotherapy","ALL","18 Years",{"count":67,"type":68},126,"ESTIMATED","OBSERVATIONAL","The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.",[72,73,74,75,76],"Osteonecrosis of the Jaw","Osteonecrosis Due to Drugs, Jaw","Osteonecrosis Due to Drug","Bisphosphonate-Associated Osteonecrosis","Bisphosphonate-Associated Osteonecrosis of the Jaw","2024-06-17",{"date":79,"type":80},"2024-06-20","ACTUAL",{"date":82,"type":80},"2021-01-01",{"date":84,"type":68},"2028-01-01",{"name":5,"class":6},1]