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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03201016
Acronym
POC
Enrollment
110
Registered
2017-06-28
Start date
2016-06-30
Completion date
2018-12-31
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

cirrhosis

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

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

Interventions

DIAGNOSTIC_TESTBone densitometry

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

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Assess the prevalence of osteoporosis and fractures in patients with hepatic cirrhosisIt 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

Secondary

MeasureTime frameDescription
Assess the associated factors risk of osteoporosis and fracturesIt is a cross-sectional prevalence study. Patients will be recruited for two years.Factors that will be studied: • Data regarding cirrhosis (etiology; alcohol/hepatitis C virus, both of them)

Other

MeasureTime frameDescription
Assess the prevalence of osteoporosis and fractures using trabecular bone scoreIt is a cross- sectional prevalence study. Patients will be recruited for two years.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.

Countries

Spain

Contacts

Primary ContactJordi Sánchez-Delgado, M.D. PhD
jsanchezd@tauli.cat937231010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026