An observational study in Osteoporosis, sponsored by Corporacion Parc Tauli. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by Corporacion Parc Tauli · Observational
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
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:
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. Additional visits to those already carried out in normal practice will not be necessary. 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
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 110 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
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Patients with hepatic cirrhosis due to hepatitis C virus or alcohol, decompensated or not decompensated and who follow controls in our hospital
Exclusion Criteria:
Procollagen Type I Propeptides, alkaline phosphatase, Crosslinked Telopeptides of Type I Collagen
Also known as: Trabecular Bone Score
Assess the prevalence of osteoporosis and fractures in patients with hepatic cirrhosis
To confirm the presence of osteoporosis and fractures in patients with cirrhosis, the investigators wil perform: - Bone Densitometry measured in standard deviations
Time frame: It is a cross-sectional prevalence study. Patients will be recruited for two years.
Assess the associated factors risk of osteoporosis and fractures
Factors that will be studied: • Data regarding cirrhosis (etiology; alcohol/hepatitis C virus, both of them)
Time frame: It is a cross-sectional prevalence study. Patients will be recruited for two years.
Assess the prevalence of osteoporosis and fractures using trabecular bone score
The TBS (Trabecular Bone Score) is derived from the evaluation of the experimental variogram, obtained from the grayscale of the bone densitometry. This score may be more sensitive to detect osteoporosis.
Time frame: It is a cross- sectional prevalence study. Patients will be recruited for two years.
Plan to share: No
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This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Corporacion Parc Tauli