Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
Recruiting · NCT04730622 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
Bone tissue histologyFrequency food questionnaireGut microbiota profilingInsulin-like growth factor 1 (IGF-1) serum levelsMuscle tissue histologyMyostatin serum levelsSARC-F questionnaire
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
- Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).
Exclusion criteria
- Previous osteoporotic fractures
- Previous prosthetic surgery for orthopedic diseases
- Pre-existing clinical conditions that led to permanent immobility
- Neoplastic diseases
- Autoimmune diseases
- Severe myopathies
- Chronic viral infections (HBV, HCV, HIV);
- Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin
- Paget's disease
Where it is running
1 location listed.
- Istituto Ortopedico Rizzoli - Bologna, Italy