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RECRUITING
NCT04730622

Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

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.

Official title: Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2020-11-23

Completion Date

2025-12-31

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

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