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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form section of this protocol). Who Should NOT Join This Trial: - Previous osteoporotic fractures - Previous prosthetic surgery for orthopedic diseases - Pre-existing clinical conditions that led to permanent immobility - Neoplastic diseases - autoimmune conditions (where your immune system attacks your own body)s - Severe myopathies - Chronic viral infections (HBV, HCV, HIV); - Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin - Paget's disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

DIAGNOSTIC_TEST

Bone tissue histology

Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Myostatin serum levels

Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.

DIAGNOSTIC_TEST

Insulin-like growth factor 1 (IGF-1) serum levels

Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.

OTHER

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.

OTHER

Gut microbiota profiling

Assessment of gut microbiome composition on stool samples.

Locations (1)

Istituto Ortopedico Rizzoli
Bologna, Italy