[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403432":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Spine Centre of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vertebroplasty","ACTIVE_COMPARATOR","Patients treated with vertebroplasty in addition to regular medical treatment.",[13],"Procedure: Vertebroplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Regular treatment","NO_INTERVENTION","Patients treated with regular medical treatment.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Injection of cement into vertebral lesion(s)",[9],[25],{"name":26,"affiliation":27,"role":28},"Mikkel Andersen, Professor","Centre of Spine Surgery and Research, Middelfart Hospital","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Line Wickstroem, MD","CONTACT","+4524411994","line.adsboll.wickstrom@rsyd.dk",{"name":26,"role":32,"phone":36,"phoneExt":18,"email":37},"+4540344069","mikkel.andersen2@rsyd.dk",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Center for Spine Surgery and Research","RECRUITING","Middelfart","Region Syddanmark","5500","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],9.73054,55.50591,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":33,"phoneExt":18,"email":34},"Line Wickstrøm, MD",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100403432","examination-of-vertebroplasty-in-addition-to-regular-treatment-of-patients-with-multiple-myeloma-100403432",false,"NCT04533217","Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.","Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.","Inclusion Criteria:\n\n* known multiple myeloma\n* verified lesion(s) between Th6-L5\n* 4 or less fractures\n* relevant pain in 3 months or less\n* vertebroplasty can be performed in one procedure\n* VAS 5 or more\n\nExclusion Criteria:\n\n* presence of neurologic deficit\n* psychological or psychiatric disorder hat is expected to interfere with compliance","ALL","18 Years",{"count":68,"type":69},90,"ESTIMATED","INTERVENTIONAL",[72],"NA","Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).",[75,76],"Vertebral Fracture","Multiple Myeloma","2024-11-27",{"date":79,"type":80},"2024-12-03","ACTUAL",{"date":82,"type":80},"2021-03-29",{"date":84,"type":69},"2026-07-31",{"name":5,"class":6},1]