Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
NCT04730622 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-05-22
Summary
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.
Conditions
- Osteoporotic Fracture of Femur
- Osteoarthritis, Hip
Interventions
- 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.
- 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.
- 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
-
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.
Sponsors & Collaborators
-
Istituto Ortopedico Rizzoli
lead OTHER
Principal Investigators
-
Nicola Baldini, M.D. · University of Bologna, Istituto Ortopedico Rizzoli
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-23
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Italy
Study Locations
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