Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

November 23, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Osteoporotic Fracture of FemurOsteoarthritis, Hip
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.

Trial Locations (1)

40136

RECRUITING

Istituto Ortopedico Rizzoli, Bologna

All Listed Sponsors
lead

Istituto Ortopedico Rizzoli

OTHER

NCT04730622 - Study of Parameters of Osteosarcopenia in Patients With Hip Fracture | Biotech Hunter | Biotech Hunter