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

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

Study Overview

• Status: Unknown
• Conditions: Osteoporosis
• Intervention / Treatment: Diagnostic test: Bone densitometry

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Corporacio Sanitaria i Universitaria Parc Tauli
      • Contact: Jordi Sánchez-Delgado, M.D. PhD; Phone Number: 29803 937231010; Email: jsanchezd@tauli.cat
      • Sub-Investigator: Enrique Casado Burgos, M.D
      • Sub-Investigator: Joaquim Profitós Font, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatic cirrhosis due to hepatitis C virus or alcohol, decompensated or not decompensated and who follow controls in our hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Jordi Sánchez-Delgado, M.D. PhD, Unitat de Malalties Digestives, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (ACTUAL): June 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Liver Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fibrosis; Liver Cirrhosis; Osteoporosis
• Other Study ID Numbers: 2015540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No