Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Assess the prevalence of osteoporosis and fractures in patients with hepatic cirrhosis
研究概览
简要总结
Osteoporosis is a common complication in chronic liver disease, especially in the late stages of the disease. Good nutrition and calcium and vitamin D supplementation are recommended for the prevention and treatment of osteoporosis. There are no specific guidelines for its pharmacological treatment, but bisphosphonates have been shown to be effective in increasing bone mass in patients with chronic cholestasis, with a good safety profile.
There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis (except for primary biliary cholangitis (PBC)). There are no clear recommendations for osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention before the onset of the complications derived would significantly improve the quality of life and decrease the morbidity and mortality associated with osteoporosis and fractures
Objective:
-To assess the prevalence of osteoporosis and fragility fractures in patients with liver cirrhosis in our country and the risk factors associated
Method:
Patients diagnosed with hepatic cirrhosis, other than PBC, will be included in any Child stage during a hospital admission. Epidemiological, demographic, clinical, analytical and imaging data (dorso-lumbar spine radiography, bone densitometry and Trabecular Bone Score) will be evaluated. A descriptive statistic of the main variables will be carried out as well as a multivariate analysis to evaluate the predictive factors of osteoporosis and / or fragility fractures
详细描述
Osteoporosis is a common complication in chronic liver disease, especially in the late stages of the disease. The main mechanism involved in the development of osteoporosis in patients with cirrhosis is the deficit of bone formation due to the harmful effect of substances such as bilirubin and bile acids or the toxic effect of alcohol or iron on osteoblasts .
Good nutrition and calcium and vitamin D supplementation are recommended for the prevention and treatment of osteoporosis. There are no specific guidelines for its pharmacological treatment, but bisphosphonates have been shown to be effective in increasing bone mass in patients with chronic cholestasis, with a good safety profile.
Hospital admissions in relation to osteoporotic fractures in cirrhotic patients are frequent with a high morbidity and mortality rate. There are few studies evaluating the prevalence of osteoporosis in patients with cirrhosis with a different etiology from PBC and the existing series are published years ago with few patient numbers. There are no clear recommendations for osteoporosis screening in cirrhotic patients. A diagnosis and early therapeutic intervention before the onset of the complications derived would significantly improve the quality of life and decrease the morbidity and mortality associated with osteoporosis and fractures
Objective:
- To assess the prevalence of osteoporosis and fragility fractures in patients with liver cirrhosis in our country.
- To assess the risk factors associated with osteoporosis and fractures in these patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give informed consent to participate in the study
- •Hepatic cirrhosis diagnosed by histological criteria or clinical, analytical and ultrasound criteria
- •Age over 18 years
排除标准
- •Ascitic decompensation (estimated ascitic fluid> 4 liters) at the time of bone densitometry
- •Patients bedridden or with very bad mobility, that makes the displacement complicated
- •Terminal illness with estimated life expectancy less than one year due to hepatic impairment or tumor disease
结局指标
主要结局
Assess the prevalence of osteoporosis and fractures in patients with hepatic cirrhosis
时间窗: It is a cross-sectional prevalence study. Patients will be recruited for two years.
To confirm the presence of osteoporosis and fractures in patients with cirrhosis, the investigators wil perform: - Bone Densitometry measured in standard deviations
次要结局
- Assess the associated factors risk of osteoporosis and fractures(It is a cross-sectional prevalence study. Patients will be recruited for two years.)
研究者
Jordi Sanchez-Delgado
Jordi Sánchez Delgado M.D; PhD. Staff of the Hepatology Unit. Digestive Diseases Department. Principal Investigator
Corporacion Parc Tauli