[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100418585":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":83,"collaborators":10,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":10,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Istituto Ortopedico Rizzoli","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fragility fracture",null,"Patients who are candidates for hip replacement surgery (endo- and arthroplasty).",[13,14,15,16,17,18,19],"Diagnostic Test: SARC-F questionnaire","Diagnostic Test: Bone tissue histology","Diagnostic Test: Muscle tissue histology","Diagnostic Test: Myostatin serum levels","Diagnostic Test: Insulin-like growth factor 1 (IGF-1) serum levels","Other: Frequency food questionnaire","Other: Gut microbiota profiling",[21,26,30,34,38,42,46],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","SARC-F questionnaire","Assessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Bone tissue histology","Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.",[9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Muscle tissue histology","Assessment of histomorphology and ultrastructure of muscle biopsies taken from the upper portion of the vastus lateralis muscle, which is accessed in the surgical procedure of hip replacement.",[9],{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Myostatin serum levels","Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.",[9],{"type":22,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Insulin-like growth factor 1 (IGF-1) serum levels","Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.",[9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Frequency food questionnaire","Assessment of dietary habits based on self-reported information about the monthly- weekly- or daily-frequency consumption of main food groups, including cereals and bread, meat, fish, fruit, vegetable, legumes, dairy products, sweets and snacks, drinks, and dietary supplements.",[9],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"Gut microbiota profiling","Assessment of gut microbiome composition on stool samples.",[9],[51],{"name":52,"affiliation":53,"role":54},"Nicola Baldini, M.D.","University of Bologna, Istituto Ortopedico Rizzoli","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":10,"email":60},"Gemma Di Pompo, M.Sc.","CONTACT","+39 0516366748","gemma.dipompo@ior.it",[62],{"facility":5,"status":63,"city":64,"state":10,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Bologna","40136","Italy","IT",{"type":69,"coordinates":70},"Point",[71,72],11.33875,44.49381,{"lat":72,"lon":71},[75,78,81],{"name":52,"role":58,"phone":76,"phoneExt":10,"email":77},"+39 051 6366560","nicola.baldini@ior.it",{"name":79,"role":80,"phone":10,"phoneExt":10,"email":10},"Alberto C Di Martino, M.D.","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":10,"phoneExt":10,"email":10},"Giorgia Borciani, M.Sc.",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100418585","study-of-parameters-of-osteosarcopenia-in-patients-with-hip-fracture-100418585",false,"NCT04730622","Study of Parameters of Osteosarcopenia in Patients With Hip Fracture","Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck","Inclusion Criteria:\n\n* Patients who came to observation with femoral neck fracture of possible osteoporotic nature (no or minimal trauma) to be treated with endoprosthesis or hip arthroplasty.\n* Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).\n\nExclusion Criteria:\n\n* Previous osteoporotic fractures\n* Previous prosthetic surgery for orthopedic diseases\n* Pre-existing clinical conditions that led to permanent immobility\n* Neoplastic diseases\n* Autoimmune diseases\n* Severe myopathies\n* Chronic viral infections (HBV, HCV, HIV);\n* Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin\n* Paget's disease","ALL","65 Years",{"count":95,"type":96},100,"ESTIMATED","OBSERVATIONAL","The study aims to assess the adequacy of a set of clinical and laboratory investigations for identifying the osteosarcopenia status in patients undergoing a hip replacement for a fragility fracture of the femoral neck. The control group will consist of patients undergoing a hip replacement for osteoarthritis, as the decrease in muscle function and bone quality is less severe in this condition than in osteoporosis.",[100,101],"Osteoporotic Fracture of Femur","Osteoarthritis, Hip",[103,104,105],"Osteoporosis","Sarcopenia","Hip prosthesis","2026-05-20",{"date":108,"type":109},"2026-05-22","ACTUAL",{"date":111,"type":109},"2020-11-23",{"date":113,"type":96},"2026-12-31",{"name":5,"class":6},1]