Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

NCT04730622 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730622 on ClinicalTrials.gov