[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640043":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":29,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":10,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":10},{"fullName":5,"class":6},"Arkansas Children's Hospital Research Institute","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with Severe Hemophilia A on Efanesoctocog alfa prophylaxis",null,"Participants with severe hemophilia A receiving prophylaxis with efanesoctocog alfa as part of routine clinical care. Participants will undergo longitudinal assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period.",{"label":13,"type":10,"description":14,"interventionNames":10},"Patients with Severe Hemophilia A on Emicizumab prophylaxis","Participants with severe hemophilia A receiving prophylaxis with emicizumab as part of routine clinical care. Participants will undergo longitudinal assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period.",[16],{"name":17,"affiliation":18,"role":19},"Divyaswathi Citla Sridhar, MD","Arkansas Children's Reserach Institute","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Carol D Pierce, RN","CONTACT","501-364-4440","piercecarold@uams.edu",{"type":19,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Divyaswathi Citla Sridhar","Associate Professor of Pediatrics",[30],{"name":31,"class":32},"Genzyme, a Sanofi Company","INDUSTRY","100640043","a-prospective-assessment-of-bone-health-in-patients-with-severe-hemophilia-a-on-factor-viii-vs-factor-mimetic-prophylaxis-efa-emi-bone-health-study-100640043",false,"NCT07582276","A Prospective Assessment of Bone Health in Patients With Severe Hemophilia A on Factor VIII vs Factor Mimetic Prophylaxis (Efa Emi Bone Health Study)","A Multi-institution Prospective Assessment of Bone Health in Patients With Severe Hemophilia A on Factor VIII vs Factor Mimetic Prophylaxis (Efa Emi Bone Health Study)","Inclusion Criteria:\n\n1. The participant or legally authorized representative is willing and able to provide written informed consent.\n2. Diagnosis of severe hemophilia A (factor VIII activity \\\u003C 1%).\n3. Male sex.\n4. Age between 30 and 50 years (inclusive).\n5. BMI between 18.5 and 40 kg\u002Fm2\n6. The participant must have been on prophylaxis with Efanesoctocog alfa or Emicizumab for at least 3 months prior to enrollment and intend to remain on the current regimen for the next 5 years.\n7. Willingness to undergo all research procedures, including DEXA scans and the collection of blood samples.\n8. Willingness to complete all standard-of-care bleeding and treatment logs.\n\nExclusion Criteria:\n\n1. Unwillingness of the participant, parent, or legally authorized representative to provide informed consent.\n2. Diagnosis of a bleeding disorder other than or in addition to severe hemophilia A.\n3. Active Factor VIII inhibitors at the time of enrollment\n4. History of a disease known to influence bone metabolism unrelated to a bleeding disorder. (Examples: Paget's disease, osteogenesis imperfecta, Ehlers Danlos syndrome, Hyperparathyroidism)\n5. Past or present treatment with any anti-osteoporotic medication, excluding oral vitamin D or oral calcium supplements.\n6. Documented HIV infection or HCV infection (whether in progress or cured) at the cirrhotic stage.\n7. Presence of a non-removable metal device that would interfere with research procedures.\n8. Inability to tolerate a DEXA scan due to limited range of motion or body habitus.\n9. History of bone fractures or surgical repair within 8 weeks prior to enrollment.\n10. Participants with weight \\>300 pounds, due to limitations of DEXA scanner","MALE","30 Years","50 Years",{"count":44,"type":45},50,"ESTIMATED","OBSERVATIONAL","This study will compare bone mineral density in patients with severe hemophilia A receiving prophylaxis with emicizumab or efanesoctocog alfa. Participants will undergo assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period. The study aims to evaluate whether differences in prophylactic therapy are associated with differences in bone health outcomes.",[49],"Hemophilia a",[51,52,53,54],"Bone Health","Emicizumab","Efanesoctocog alfa","hemophilia","NOT_YET_RECRUITING","2026-06-03",{"date":58,"type":59},"2026-06-04","ACTUAL",{"date":61,"type":45},"2026-07-01",{"date":63,"type":45},"2032-08-01",{"name":5,"class":6}]