Cirrhosis Clinical Trial
Official title:
PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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