Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors

Osteoporosis Clinical Trial

— POC  

Official title:

Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201016
• Other study ID #: 2015540
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: June 26, 2017
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Corporacion Parc Tauli
• Contact: Jordi Sánchez-Delgado, M.D. PhD
• Phone: 937231010
• Email: jsanchezd[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2018
• Est. primary completion date: June 2017
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Give informed consent to participate in the study

• Hepatic cirrhosis diagnosed by histological criteria or clinical, analytical and ultrasound criteria

• Age over 18 years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Osteoporosis

Intervention

Diagnostic Test:
• Bone densitometry
Procollagen Type I Propeptides, alkaline phosphatase, Crosslinked Telopeptides of Type I Collagen

Locations

Country	Name	City	State
Spain	Corporació Sanitària i Universitària Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	It is a cross- sectional prevalence study. Patients will be recruited for two years.
Primary	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	It is a cross-sectional prevalence study. Patients will be recruited for two years.
Secondary	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)	It is a cross-sectional prevalence study. Patients will be recruited for two years.