[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484661":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":130,"collaborators":10,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":10,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":10,"enrollmentInfo":141,"targetDuration":10,"studyType":144,"phases":10,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Post- menopausal breast cancer patients",null,"Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors\u002FAI prior to or within 6 months of stopping denosumab",[13,14,15],"Other: Physical Evaluation","Diagnostic Test: Dual-energy X-ray absorptiometry scans","Diagnostic Test: Trabecular Bone Score",[17,21,28],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"Physical Evaluation","Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed).",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Dual-energy X-ray absorptiometry scans","Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.",[9],[27],"DEXA scans",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Trabecular Bone Score","TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.",[9],[33],"TBS",[35],{"name":36,"affiliation":5,"role":37},"Monica Fornier, MD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","646-888-4563","fornierm@mskcc.org",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":46},"Azeez Farooki, MD","646-608-3798","farookia@mskcc.org",[48,64,75,86,98,109,119],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-74.54932,40.70621,{"lat":60,"lon":59},[63],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":10},{"facility":65,"status":50,"city":66,"state":52,"zip":67,"country":54,"countryCode":55,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":57,"coordinates":69},[70,71],-74.11709,40.39428,{"lat":71,"lon":70},[74],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":10},{"facility":76,"status":50,"city":77,"state":52,"zip":78,"country":54,"countryCode":55,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":57,"coordinates":80},[81,82],-74.02292,41.04676,{"lat":82,"lon":81},[85],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":10},{"facility":87,"status":50,"city":88,"state":89,"zip":90,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)","Commack","New York","11725",{"type":57,"coordinates":92},[93,94],-73.29289,40.84288,{"lat":94,"lon":93},[97],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":10},{"facility":99,"status":50,"city":100,"state":89,"zip":101,"country":54,"countryCode":55,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":57,"coordinates":103},[104,105],-73.71263,40.96899,{"lat":105,"lon":104},[108],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":10},{"facility":5,"status":50,"city":89,"state":89,"zip":110,"country":54,"countryCode":55,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"10065",{"type":57,"coordinates":112},[113,114],-74.00597,40.71427,{"lat":114,"lon":113},[117],{"name":36,"role":40,"phone":118,"phoneExt":10,"email":10},"646-888-5240",{"facility":120,"status":50,"city":121,"state":89,"zip":122,"country":54,"countryCode":55,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"type":57,"coordinates":124},[125,126],-73.59291,40.70038,{"lat":126,"lon":125},[129],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":10},{"type":131,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100484661","observational-study-of-bone-complications-in-people-with-post-menopausal-breast-cancer-who-have-stopped-treatment-with-denosumab-and-aromatase-inhibitors-100484661",false,"NCT05590949","Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors","Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation","Inclusion Criteria:\n\n* Women with confirmed diagnosis of breast cancer\n* Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment\n* Received at least 2 doses of denosumab and then discontinued therapy\n* Discontinued AI prior to or within 6 months of last denosumab injection\n* Patients must be 18 years of age or olde\n\nExclusion Criteria:\n\n* Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;\n* Patients with history of insufficiency fracture.\n* Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab\n* Patients on chronic low-dose glucosteroids.","FEMALE","18 Years",{"count":142,"type":143},100,"ESTIMATED","OBSERVATIONAL","The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor\u002FAI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.",[147],"Breast Cancer",[149,147,150,151,152,5],"Post-menopausal Breast Cancer","Denosumab","Aromatase","22-280","2026-08-18",{"date":155,"type":156},"2026-08-20","ACTUAL",{"date":158,"type":156},"2022-10-18",{"date":160,"type":143},"2026-10-18",{"name":5,"class":6},7]