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Trial record 22 of 154 for:    Recruiting, Not yet recruiting, Available Studies | "Osteoporosis"

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

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ClinicalTrials.gov Identifier: NCT03201016
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Jordi Sanchez-Delgado, Corporacion Parc Tauli

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


Condition or disease Intervention/treatment
Osteoporosis 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 [Patient Registry]
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prevalence of Osteoporosis and Fractures in Patients With Hepatic Cirrhosis and Investigation of the Associated Factors
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Bone densitometry
    Procollagen Type I Propeptides, alkaline phosphatase, Crosslinked Telopeptides of Type I Collagen
    Other Name: Trabecular Bone Score


Primary Outcome Measures :
  1. Assess the prevalence of osteoporosis and fractures in patients with hepatic cirrhosis [ Time Frame: It 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 Outcome Measures :
  1. Assess the associated factors risk of osteoporosis and fractures [ Time Frame: It 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 Outcome Measures:
  1. Assess the prevalence of osteoporosis and fractures using trabecular bone score [ Time Frame: It 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201016


Contacts
Contact: Jordi Sánchez-Delgado, M.D. PhD 937231010 ext 29803 jsanchezd@tauli.cat

Locations
Spain
Corporació Sanitària i Universitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Jordi Sánchez-Delgado, M.D. PhD    937231010 ext 29803    jsanchezd@tauli.cat   
Sub-Investigator: Enrique Casado Burgos, M.D         
Sub-Investigator: Joaquim Profitós Font, M.D         
Sponsors and Collaborators
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

Responsible Party: Jordi Sanchez-Delgado, Jordi Sánchez Delgado M.D; PhD. Staff of the Hepatology Unit. Digestive Diseases Department. Principal Investigator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03201016     History of Changes
Other Study ID Numbers: 2015540
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordi Sanchez-Delgado, Corporacion Parc Tauli:
cirrhosis

Additional relevant MeSH terms:
Osteoporosis
Fibrosis
Liver Cirrhosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases