Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)
时间窗: 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.
Acceptability of the Frequency Food Questionnaire
时间窗: 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)
时间窗: Within 24 hours of admission
The percentages of cases (fragility fractures) and controls (osteoarthritis) who assume never/rarely or regularly the different food categories.
Acceptability of the SARC-F questionnaire
时间窗: 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)
时间窗: 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)
时间窗: 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.
Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis)
时间窗: 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)
时间窗: 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.
次要结局
- 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.)
- Frequency of intake of the different food categories 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 osteoporotic bone(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.)
- Insulin-like growth factor 1 (IGF-1) 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.)
- Inflammatory serum markers(Through study completion, an average of 1 year.)
- Insulin-like growth factor 1 (IGF-1) serum levels in patients with positive and negative SARC-F questionnaire(Through study completion, an average of 1 year.)
- Frequency of intake of the different food categories in patients with positive and negative SARC-F questionnaire(Within 24 hours of admission)
- Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without muscle atrophy(Through study completion, an average of 1 year.)
- Frequency of intake of the different food categories in patients with and without muscle atrophy(Through study completion, an average of 1 year.)
- Serum markers of bone metabolism(Through study completion, an average of 1 year.)