Osteoarthritis, Hip Clinical Trial
Official title:
Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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). | Through study completion, an average of 1 year. | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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 | 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. | Through study completion, an average of 1 year. | |
Secondary | 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. | Through study completion, an average of 1 year. | |
Secondary | 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. | Through study completion, an average of 1 year. | |
Secondary | 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. | Through study completion, an average of 1 year. | |
Secondary | Myostatin serum levels in patients with and without muscle atrophy | Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without muscle atrophy. | Through study completion, an average of 1 year. | |
Secondary | Insulin-like growth factor 1 (IGF-1) serum levels in patients with positive and negative SARC-F questionnaire | 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. | Through study completion, an average of 1 year. | |
Secondary | Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without osteoporotic bone | Mean ± standard error of the mean, median, and min-max range of circulating IGF-1 (µg/L) in patients with and without osteoporotic bone. | Through study completion, an average of 1 year. | |
Secondary | Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without muscle atrophy | Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without muscle atrophy. | Through study completion, an average of 1 year. | |
Secondary | Frequency of intake of the different food categories in patients with positive and negative SARC-F questionnaire | The percentage of patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire who assume never/rarely and regularly the different food categories. | Within 24 hours of admission | |
Secondary | Frequency of intake of the different food categories in patients with and without osteoporotic bone | The percentage of patients with and without osteoporotic bone who assume never/rarely and regularly the different food categories. | Through study completion, an average of 1 year. | |
Secondary | Frequency of intake of the different food categories in patients with and without muscle atrophy | The percentage of patients with and without muscle atrophy who assume never/rarely and regularly the different food categories. | Through study completion, an average of 1 year. | |
Secondary | Inflammatory serum markers | Mean ± standard error of the mean, median, and min-max range of circulating IL-6, IL-8, TNF-a in patients | Through study completion, an average of 1 year. | |
Secondary | Serum markers of bone metabolism | Mean ± standard error of the mean, median, and min-max range of circulating FGF-21, GDF15, ST2 in patients | Through study completion, an average of 1 year. |
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