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

Phase 4

Completed

• Conditions: Cirrhosis
• Interventions: Drug: Treated with Ibandronic acid as per protocol

• Registration Number: NCT02249741
• Lead Sponsor: Dr. Ashish Kumar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-25
• Last Update Submitted: 2014-09-25
• Study First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with osteoporosis	Treated with Ibandronic acid as per protocol	Treated with Ibandronic acid as per protocol

Primary Outcome Measures

Name	Time	Method
Improvement in Bone Mineral Density on DEXA scan	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of new fractures	6 months

Trial Locations

Locations (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India