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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Treated with Ibandronic acid as per protocol
Sponsored by
Dr. Ashish Kumar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with osteoporosis

Arm Description

Treated with Ibandronic acid as per protocol

Outcomes

Primary Outcome Measures

Improvement in Bone Mineral Density on DEXA scan

Secondary Outcome Measures

Incidence of new fractures

Full Information

First Posted
September 23, 2014
Last Updated
September 25, 2014
Sponsor
Dr. Ashish Kumar
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1. Study Identification

Unique Protocol Identification Number
NCT02249741
Brief Title
Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation
Official Title
PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Ashish Kumar

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with osteoporosis
Arm Type
Experimental
Arm Description
Treated with Ibandronic acid as per protocol
Intervention Type
Drug
Intervention Name(s)
Treated with Ibandronic acid as per protocol
Intervention Description
treated with Ibandronic acid at a dose of 150 mg once a month for six months
Primary Outcome Measure Information:
Title
Improvement in Bone Mineral Density on DEXA scan
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of new fractures
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver Cirrhosis Age 18-70 years Informed and written consent Exclusion Criteria: Chronic renal failure Prolonged steroid use more than 3 months Patients on immunosuppressive therapy Primary hyperparathyroidism Post menopausal women Pregnancy Cushing's syndrome Malignancy HIV Co-infection
Facility Information:
Facility Name
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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