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

NCT03201016 | Unknown DMC

• 1 other identifier: 2015540
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoporosis

Keywords

cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess the associated factors risk of osteoporosis and fractures

  It is a cross-sectional prevalence study. Patients will be recruited for two years.

Other Outcomes (1)

• Assess the prevalence of osteoporosis and fractures using trabecular bone score

  It is a cross- sectional prevalence study. Patients will be recruited for two years.

Interventions

Bone densitometry DIAGNOSTIC_TEST

Procollagen Type I Propeptides, alkaline phosphatase, Crosslinked Telopeptides of Type I Collagen

Also known as: Trabecular Bone Score

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Give informed consent to participate in the study
• Hepatic cirrhosis diagnosed by histological criteria or clinical, analytical and ultrasound criteria
• Age over 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporació Sanitària i Universitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Fibrosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordi Sánchez-Delgado, M.D. PhD

  Unitat de Malalties Digestives, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Sánchez-Delgado, M.D. PhD

CONTACT

937231010; jsanchezd@tauli.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jordi Sánchez Delgado M.D; PhD. Staff of the Hepatology Unit. Digestive Diseases Department. Principal Investigator

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 28, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)