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

Information source: Sir Ganga Ram Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis

Intervention: Treated with Ibandronic acid as per protocol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Dr. Ashish Kumar

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.

Clinical Details

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

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

Primary outcome: Improvement in Bone Mineral Density on DEXA scan

Secondary outcome: Incidence of new fractures

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital, New Delhi 110060, India
Additional Information

Starting date: August 2012
Last updated: September 25, 2014

Page last updated: August 23, 2015

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