RecruitingNCT04730622

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

100 participants

Start Date

Nov 23, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Bone tissue histology, Frequency food questionnaire, and others for people with osteoarthritis, hip and osteoporotic fracture of femur. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSARC-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_TESTBone tissue histology

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

DIAGNOSTIC_TESTMuscle 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_TESTMyostatin serum levels

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

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

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

OTHERFrequency 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.

OTHERGut microbiota profiling

Assessment of gut microbiome composition on stool samples.


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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NCT04730622


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