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

NCT02249741 | Completed Phase 4

• 1 other identifier: Gastro-2012-RB-1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Improvement in Bone Mineral Density on DEXA scan

  6 months

Secondary Outcomes (1)

• Incidence of new fractures

  6 months

Study Arms (1)

Patients with osteoporosis

EXPERIMENTAL

Treated with Ibandronic acid as per protocol

Drug: Treated with Ibandronic acid as per protocol

Interventions

Treated with Ibandronic acid as per protocol DRUG

treated with Ibandronic acid at a dose of 150 mg once a month for six months

Patients with osteoporosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver Cirrhosis
• Age 18-70 years
• Informed and written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Ashish Kumar: lead

Study Sites (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

New Delhi, New Delhi, 110060, India

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Therapeutics; Ibandronic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

IN (1)