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

Dr. Ashish Kumar

Status and phase: Completed; Phase 4

Conditions: Cirrhosis

Treatments: Drug: Treated with Ibandronic acid as per protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02249741

Gastro-2012-RB-1

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Patients with osteoporosis

Experimental group

Description:

Treated with Ibandronic acid as per protocol

Treatment:

Drug: Treated with Ibandronic acid as per protocol