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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02249741
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Information provided by (Responsible Party):
Dr. Ashish Kumar, Sir Ganga Ram Hospital

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: Treated with Ibandronic acid as per protocol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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

Primary Outcome Measures :
  1. Improvement in Bone Mineral Density on DEXA scan [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of new fractures [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02249741

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Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Dr. Ashish Kumar
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Responsible Party: Dr. Ashish Kumar, Associate Professor, Sir Ganga Ram Hospital Identifier: NCT02249741    
Other Study ID Numbers: Gastro-2012-RB-1
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs