[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571445":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":55,"responsibleParty":74,"collaborators":31,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":98,"whyStopped":31,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Marmara University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Romosozumab and denosumab combination","EXPERIMENTAL","Romosozumab 210 mg subcutaneously per month combined with denosumab 60mg subcutaneously per 6 months",[13],"Drug: Romosozumab and Denosumab Combination Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Romosozumab","ACTIVE_COMPARATOR","Romosozumab 210 mg subcutaneously per month",[19],"Drug: Romosozumab Prefilled Syringe [Evenity]",{"label":21,"type":16,"description":22,"interventionNames":23},"Denosumab","denosumab 60mg subcutaneously per 6 months",[24],"Drug: Denosumab (Prolia)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Romosozumab and Denosumab Combination Therapy","Romosozumab 210mg per month and denosumab 60mg per 6 months will be applied",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Romosozumab Prefilled Syringe [Evenity]","Romosozumab 210mg subcutaneously per month",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Denosumab (Prolia)","Denosumab 60 mg subcutaneously per 6 months",[21],[41],{"name":42,"affiliation":43,"role":44},"Canan Sanal, Associate Profesor","Marmara University Medical School","STUDY_DIRECTOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Muhammed Selim Eryılmaz, Resident","CONTACT","+905424848329","selimerylmz@gmail.com",{"name":52,"role":48,"phone":53,"phoneExt":31,"email":54},"Canan Şanal, Associate Profesor","+905331381032","canansanal@gmail.com",[56],{"facility":5,"status":31,"city":57,"state":31,"zip":31,"country":58,"countryCode":31,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Istanbul","Turkey (Türkiye)",{"type":60,"coordinates":61},"Point",[62,63],28.94966,41.01384,{"lat":63,"lon":62},[66,69,72,73],{"name":67,"role":48,"phone":68,"phoneExt":31,"email":54},"Canan Şanal, Associate Proffesor","+90 533 138 10 32",{"name":70,"role":48,"phone":71,"phoneExt":31,"email":50},"Muhammed Selim Eryılmaz","+90 5424848329",{"name":52,"role":48,"phone":31,"phoneExt":31,"email":31},{"name":70,"role":48,"phone":31,"phoneExt":31,"email":31},{"type":75,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100571445","phase-4-efficacy-of-romosozumab-and-denosumab-combined-treatment-in-postmenopausal-osteoporosis-patients-with-multiple-fragility-fractures-100571445",false,"NCT06720350","Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures","MORD","Inclusion Criteria:\n\n* Postmenopausal Women\n* Patients with Osteoporosis\n* Patients aged between 55 and 85 years old\n\nExclusion Criteria:\n\n* Patient with history of Serebrovascular diseases\n* Patient with history of Miyocardial Infarction\n* Patients who have calcium metabiolism disturbances\n* Patients with chronic kidney diseases\n* Patient with history of allergic reactions to denosumab or romosozumab","FEMALE","55 Years","85 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is under at least 2 years of denosumab treatment. The main questions aimed to answer are:\n\n* Does it effective to prevent fractures add Romosozumab to ongoing denosumab treatment?\n* If it is appropiate to quit denosumab for starting 1 year romosozumab treatment?\n* If there is complications in denosumab and romosozumab combination treatment?\n\nResearchers will compare the Romosozumab 210mg subcutaneous(sc) monthly plus denosumab 60mg per 6 months sc treatment to prooceeding denosumab treatment and romosozumab 210mg monthly treatment in patient whom denosumab cessaced.\n\nParticipians are postmenopousal women with osteoporosis and they are under at least 2 years of treatment with denosumab and they will:\n\n* Add 210 mg monthly romosozumab sc injection or switch to 210 mg monthly romosozumab sc injection or proceed 60mg per 6 months denosumab sc injection\n* Visit the clinic at least once every 3 months and first month of new treatment regimen, blood tests per 3 months and Bone mineral density examination per 6 months\n* Keep a diary of their symptoms",[94],"Osteoporosis in Post-menopausal Women",[96,97,15,21],"Osteoporosis","Combination Therapy","NOT_YET_RECRUITING","2024-12-25",{"date":101,"type":102},"2024-12-27","ACTUAL",{"date":104,"type":88},"2025-01-15",{"date":106,"type":88},"2026-12-15",{"name":5,"class":6},1]