Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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.

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

Insulin-like growth factor 1 (IGF-1) serum levels: Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.

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.

Gut microbiota profiling: Assessment of gut microbiome composition on stool samples.

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.

Eligibility

Primary outcome measure(s)

• Acceptability of the SARC-F questionnaire — Within 24 hours of admission
  The number of patients able to provide answers divided by the total number of enrolled patients.
• Frequency of positive SARC-F questionnaire in cases (fragility fractures) and controls (osteoarthritis) — Within 24 hours of admission
  The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit a positive SARC-F questionnaire. The SARC-F is positive and indicates potential sarcopenia if the score point is = or \> 4. For each component of the questionnaire (grip strength, assistance with walking, rising from a chair, climbing stairs, and falls), the score may be 0 (no difficulty; no falls), 1 (some difficulty), and 2 (a lot of difficulties and falls). The total score may range from 0 to 10.
• Presence of histological features of osteoporotic bone in cases (fragility fractures) and controls (osteoarthritis) — Through study completion, an average of 1 year.
  The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit histological features of osteoporotic bone. The presence of osteoporotic bone will be proved based on the following histological features: loss of connected trabecular bone, altered matrix mineralization, the prevalence of adipose tissue compared to bone marrow, presence of osteoclasts.
• Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis) — Through study completion, an average of 1 year.
  The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit histological features of muscle atrophy. The presence of muscle atrophy will be proved based on the following histological features: decrease in size and number of type II myofibers, presence of necrosis or fibro-adipose replacement, decrease in satellite cell number.
• Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis) — Through study completion, an average of 1 year.
  The immunoenzymatic quantification of circulating Myostatin (µg/L) will be performed on serum samples obtained from peripheral venous blood. The results will be aggregated as mean ± standard error of the mean, median, and min-max range.
• Insulin-like growth factor 1 (IGF-1) serum levels in cases (fragility fractures) and controls (osteoarthritis) — Through study completion, an average of 1 year.
  The immunoenzymatic quantification of circulating IGF-1 (µg/L) will be performed on serum samples obtained from peripheral venous blood. The results will be aggregated as mean ± standard error of the mean, median, and min-max range.
• Acceptability of the Frequency Food Questionnaire — Within 24 hours of admission
  The number of patients able to provide answers divided by the total number of enrolled patients.
• Frequency of intake of the different food categories in cases (fragility fractures) and controls (osteoarthritis) — Within 24 hours of admission
  The percentages of cases (fragility fractures) and controls (osteoarthritis) who assume never/rarely or regularly the different food categories.

Trial sites (1)

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