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NCT Number: NCT04730622

Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

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.

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Key information

Conditions

Osteoporotic Fracture of Femur Arthritis Atrophy Bone Diseases Bone Diseases, Metabolic Joint Diseases Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoarthritis Osteoarthritis, Hip Osteoporosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Alberto C Di Martino, M.D.

SUB_INVESTIGATOR

Giorgia Borciani, M.Sc.

SUB_INVESTIGATOR

Nicola Baldini, M.D.

CONTACT

[email protected]

+39 051 6366560

About this study

Osteoporotic hip fractures (fragility fractures) are common in older adults, and the risk of adverse outcomes and mortality is higher in patients affected by osteosarcopenia, a geriatric syndrome in which the low bone mineral density and bone microarchitecture deterioration (osteopenia/osteoporosis) are combined with a decline in mass, strength, and functional capacity of skeletal muscle (sarcopenia).

The diagnostic workup currently recommended to establish the severity of osteosarcopenia is hard to implement in individuals who arrive at the orthopedic emergency department with a fragility fracture. On the one hand, the evaluation of motility and physical performance is impracticable in bedridden patients; on the other hand, the surgical treatment priority does not allow performing all the instrumental investigations required for a proper diagnosis. In this context, reliable osteosarcopenia biomarkers could help identify most frail patients and plan for them personalized therapeutic interventions to promote postoperative recovery and reduce the risk of adverse outcomes.

Based on the new knowledge on the pathophysiology of osteosarcopenia, the investigators designed a small-scale study that aims to preliminarily verify the adequacy of a set of clinical and laboratory parameters that could be easily applied in hospitalized patients undergoing hip replacement for a fragility fracture. In particular, the investigators planned to assess the following:

  • muscle performance by SARC-F questionnaire (acronym deriving from five domains considered in the questionnaire, i.e., strength, assistance with walking, rising from a chair, climbing stairs, and falls);
  • dietary habits through a questionnaire on the intake frequency of food categories;
  • histological features of osteoporosis and sarcopenia in tissue samples taken from the surgical site;
  • the serum levels of markers associated with muscle-bone cross-talk (Myostatin, Insulin-like growth factor 1);
  • the serum levels of the following pro-inflammatory cytokines to get a clearer picture of the presence of the inflammatory state: IL-6, IL-8, TNF-α;
  • the serum levels of markers such as FGF-21, GDF15, soluble ST2, interesting markers of bone metabolism, indicators of bone mineral density, and modulators of osteoblast-osteoclast activity;
  • the composition of the gut microbiota.

The study includes 100 patients who are candidates for hip replacement surgery (endo- and arthroplasty). As the decrease in muscle function and bone quality is more severe in fragility fractures than in osteoarthritis, the investigators expect to find differences in laboratory and clinical parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who came to observation with femoral neck fracture of possible osteoporotic nature (no or minimal trauma) to be treated with endoprosthesis or hip arthroplasty.
  • Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).

Exclusion criteria

  • Previous osteoporotic fractures
  • Previous prosthetic surgery for orthopedic diseases
  • Pre-existing clinical conditions that led to permanent immobility
  • Neoplastic diseases
  • Autoimmune diseases
  • Severe myopathies
  • Chronic viral infections (HBV, HCV, HIV);
  • Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin
  • Paget's disease

Treatment and study plan

SARC-F questionnaire

Diagnostic Test

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

Diagnostic Test

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

Muscle tissue histology

Diagnostic Test

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

Diagnostic Test

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

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

Diagnostic Test

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

Frequency food questionnaire

Other

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

Other

Assessment of gut microbiome composition on stool samples.

Primary outcomes

  1. Acceptability of the SARC-F questionnaire

    Time frame: Within 24 hours of admission

    The number of patients able to provide answers divided by the total number of enrolled patients.

  2. Frequency of positive SARC-F questionnaire in cases (fragility fractures) and controls (osteoarthritis)

    Time frame: 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.

  3. Presence of histological features of osteoporotic bone in cases (fragility fractures) and controls (osteoarthritis)

    Time frame: 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.

  4. Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)

    Time frame: 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.

  5. Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis)

    Time frame: 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.

  6. Insulin-like growth factor 1 (IGF-1) serum levels in cases (fragility fractures) and controls (osteoarthritis)

    Time frame: 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.

  7. Acceptability of the Frequency Food Questionnaire

    Time frame: Within 24 hours of admission

    The number of patients able to provide answers divided by the total number of enrolled patients.

  8. Frequency of intake of the different food categories in cases (fragility fractures) and controls (osteoarthritis)

    Time frame: Within 24 hours of admission

    The percentages of cases (fragility fractures) and controls (osteoarthritis) who assume never/rarely or regularly the different food categories.

Secondary outcomes

  1. Frequency of positive SARC-F questionnaire in patients with and without osteoporotic bone

    Time frame: Through study completion, an average of 1 year.

    The percentage of patients with and without osteoporotic bone who exhibit a positive (= or > 4) or negative (< 4) SARC-F questionnaire.

  2. Frequency of positive SARC-F questionnaire in patients with and without muscle atrophy

    Time frame: Through study completion, an average of 1 year.

    The percentage of patients with and without muscle atrophy who exhibit a positive (= or > 4) or negative (< 4) SARC-F questionnaire.

  3. Myostatin serum levels in patients with positive and negative SARC-F questionnaire

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire.

  4. Myostatin serum levels in patients with and without osteoporotic bone

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without osteoporotic bone.

  5. Myostatin serum levels in patients with and without muscle atrophy

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without muscle atrophy.

  6. Insulin-like growth factor 1 (IGF-1) serum levels in patients with positive and negative SARC-F questionnaire

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating IGF-1 (µg/L) in patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire.

  7. Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without osteoporotic bone

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating IGF-1 (µg/L) in patients with and without osteoporotic bone.

  8. Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without muscle atrophy

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without muscle atrophy.

  9. Frequency of intake of the different food categories in patients with positive and negative SARC-F questionnaire

    Time frame: Within 24 hours of admission

    The percentage of patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire who assume never/rarely and regularly the different food categories.

  10. Frequency of intake of the different food categories in patients with and without osteoporotic bone

    Time frame: Through study completion, an average of 1 year.

    The percentage of patients with and without osteoporotic bone who assume never/rarely and regularly the different food categories.

  11. Frequency of intake of the different food categories in patients with and without muscle atrophy

    Time frame: Through study completion, an average of 1 year.

    The percentage of patients with and without muscle atrophy who assume never/rarely and regularly the different food categories.

  12. Inflammatory serum markers

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating IL-6, IL-8, TNF-α in patients

  13. Serum markers of bone metabolism

    Time frame: Through study completion, an average of 1 year.

    Mean ± standard error of the mean, median, and min-max range of circulating FGF-21, GDF15, ST2 in patients

Other outcomes

  1. Characterization of gut microbiota

    Time frame: Through study completion, an average of 1 year.

    The "Next Generation Sequencing" technology will be employed to characterize the overall microbiome profile in stool samples, and bioinformatics used to assess alpha-diversity (ecological diversity of a single sample according to the number of different taxa and their relative abundances) and beta-diversity (differences in microbial community composition between individuals).

Study contacts

Contact information is provided by the study sponsor or research team.

Gemma Di Pompo, M.Sc.

CONTACT

[email protected]

+39 0516366748

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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