Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorIstituto Ortopedico Rizzoli
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Previous osteoporotic fractures
Previous prosthetic surgery for orthopedic diseases
Pre-existing clinical conditions that led to permanent immobility
Neoplastic diseases
Trial population
Hospitalized patients admitted at the 1st Orthopaedic and Traumatology Unit of the Istituto Ortopedico Rizzoli (Bologna, Italy).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SARC-F questionnaire
Diagnostic testAssessment 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 testAssessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
Muscle tissue histology
Diagnostic testAssessment 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 testQuantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
Insulin-like growth factor 1 (IGF-1) serum levels
Diagnostic testQuantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
Frequency food questionnaire
Other interventionAssessment 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 interventionAssessment of gut microbiome composition on stool samples.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Fragility fracture7 interventions
Trial outcomes
Primary outcomes
1
Acceptability of the SARC-F questionnaire
The number of patients able to provide answers divided by the total number of enrolled patients.
Time frame
Within 24 hours of admission2
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.
Time frame
Within 24 hours of admission3
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.
Time frame
Through study completion, an average of 1 year.4
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.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
Frequency of positive SARC-F questionnaire in patients with and without osteoporotic bone
The percentage of patients with and without osteoporotic bone who exhibit a positive (= or \> 4) or negative (\< 4) SARC-F questionnaire.
Time frame
Through study completion, an average of 1 year.2
Frequency of positive SARC-F questionnaire in patients with and without muscle atrophy
The percentage of patients with and without muscle atrophy who exhibit a positive (= or \> 4) or negative (\< 4) SARC-F questionnaire.
Time frame
Through study completion, an average of 1 year.3
Myostatin serum levels in patients with positive and negative SARC-F questionnaire
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.
Time frame
Through study completion, an average of 1 year.4
Myostatin serum levels in patients with and without osteoporotic bone
Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without osteoporotic bone.
Time frame
Through study completion, an average of 1 year.Other outcomes
1
Characterization of gut microbiota
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).
Time frame
Through study completion, an average of 1 year.Sponsors and contacts
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Source ClinicalTrials.gov