Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation

September 25, 2014 updated by: Dr. Ashish Kumar

PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION

Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of HOD in Indian population and its treatment outcome. The investigators aimed to determine prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone mineral density in patients with liver cirrhosis.

Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in female) and parathyroid hormone (PTH) along with routine investigations. Transient elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six months was given in patients with osteoporosis and DEXA scan repeated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110060
        • Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Liver Cirrhosis
  2. Age 18-70 years
  3. Informed and written consent

Exclusion Criteria:

  1. Chronic renal failure
  2. Prolonged steroid use more than 3 months
  3. Patients on immunosuppressive therapy
  4. Primary hyperparathyroidism
  5. Post menopausal women
  6. Pregnancy
  7. Cushing's syndrome
  8. Malignancy
  9. HIV Co-infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with osteoporosis
Treated with Ibandronic acid as per protocol
Drug: Treated with Ibandronic acid as per protocol
treated with Ibandronic acid at a dose of 150 mg once a month for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Bone Mineral Density on DEXA scan
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of new fractures
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Ashish Kumar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastro-2012-RB-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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