Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

NCT04730622 | Recruiting DMC

• 1 other identifier: OsteoSarcopenia
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Osteoporosis; Sarcopenia; Hip prosthesis

Outcome Measures

Primary Outcomes (8)

• Acceptability of the SARC-F questionnaire

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

  Within 24 hours of admission

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

  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.

  Within 24 hours of admission

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

  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.

  Through study completion, an average of 1 year.

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

  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.

  Through study completion, an average of 1 year.

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

  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.

  Through study completion, an average of 1 year.

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

  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.

  Through study completion, an average of 1 year.

• Acceptability of the Frequency Food Questionnaire

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

  Within 24 hours of admission

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

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

  Within 24 hours of admission

Secondary Outcomes (13)

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

  Through study completion, an average of 1 year.

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

  Through study completion, an average of 1 year.

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

  Through study completion, an average of 1 year.

• Myostatin serum levels in patients with and without osteoporotic bone

  Through study completion, an average of 1 year.

• Myostatin serum levels in patients with and without muscle atrophy

  Through study completion, an average of 1 year.

Other Outcomes (1)

• Characterization of gut microbiota

  Through study completion, an average of 1 year.

Study Arms (1)

Fragility fracture

Patients who are candidates for hip replacement surgery (endo- and arthroplasty).

Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Bone tissue histology; Diagnostic Test: Muscle tissue histology; Diagnostic Test: Myostatin serum levels; Diagnostic Test: Insulin-like growth factor 1 (IGF-1) serum levels; Other: Frequency food questionnaire; Other: Gut microbiota profiling

Interventions

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.

Fragility fracture

Bone tissue histology DIAGNOSTIC_TEST

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

Fragility fracture

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.

Fragility fracture

Myostatin serum levels DIAGNOSTIC_TEST

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

Fragility fracture

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.

Fragility fracture

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.

Fragility fracture

Gut microbiota profiling OTHER

Assessment of gut microbiome composition on stool samples.

Fragility fracture

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients admitted at the 1st Orthopaedic and Traumatology Unit of the Istituto Ortopedico Rizzoli (Bologna, Italy).

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (3)

• Kirk B, Zanker J, Duque G. Osteosarcopenia: epidemiology, diagnosis, and treatment-facts and numbers. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):609-618. doi: 10.1002/jcsm.12567. Epub 2020 Mar 22.

  PMID: 32202056 BACKGROUND

• Wong RMY, Wong H, Zhang N, Chow SKH, Chau WW, Wang J, Chim YN, Leung KS, Cheung WH. The relationship between sarcopenia and fragility fracture-a systematic review. Osteoporos Int. 2019 Mar;30(3):541-553. doi: 10.1007/s00198-018-04828-0. Epub 2019 Jan 4.

  PMID: 30610245 BACKGROUND

• Kirk B, Al Saedi A, Duque G. Osteosarcopenia: A case of geroscience. Aging Med (Milton). 2019 Sep 8;2(3):147-156. doi: 10.1002/agm2.12080. eCollection 2019 Sep.

  PMID: 31942528 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tissue, serum, stools

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoporosis; Sarcopenia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nicola Baldini, M.D.

  University of Bologna, Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gemma Di Pompo, M.Sc.

CONTACT

+39 0516366748; gemma.dipompo@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 29, 2021
• Study Start: November 23, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

IT (1)