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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249741
• Other study ID #: Gastro-2012-RB-1
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2014
• Last updated: September 25, 2014
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Sir Ganga Ram Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• Treated with Ibandronic acid as per protocol
treated with Ibandronic acid at a dose of 150 mg once a month for six months

Locations

Country	Name	City	State
India	Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Ashish Kumar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Bone Mineral Density on DEXA scan		6 months	Yes
Secondary	Incidence of new fractures		6 months	Yes