Status:
UNKNOWN
Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatic Osteodystrophy
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Hepatic osteodystrophy(HOD) is a common but frequently overlooked complication of liver cirrhosis with a prevalence rate ranging from 13-70%. Bisphosphonates acting by inhibiting bone resorption are f...
Detailed Description
Hypothesis : Oral ibandronate 150 mg once monthly significantly improves BMD in patients of liver cirrhosis with hepatic osteodystrophy by decreasing bone resorption \& is safe in patients with low ri...
Eligibility Criteria
Inclusion
- Liver cirrhosis patients between 18 to 70 yrs with low risk esophageal varices and HOD (osteoporosis/osteopenia will be enrolled).
- Patient and attendants willing to give informed consent
Exclusion
- Age \<18 years and \> 70 years
- Patients with prior history of fracture
- History of upper GI bleed in last 2 months
- Patients with post EVL ulcers
- High risk esophageal varices or gastric varices without endoscopic treatment.
- Active peptic ulcer
- Severe vascular ectasia
- Esophageal stricture
- Achalasia
- Creatinine clearance below 30ml/min
- Malignancy(except HCC)
- Hyperparathyroidism
- Patients using NSAIDs, corticosteroids ,anticoagulants or ongoing alcohol beverages
- Bisphosphonate hypersensitivity/Oral bisphosphonate within 12 months
- Grade 2/3 ascites
- Hepatic encephalopathy(Grade 3 \&4)
- Critically ill patients
- Post LT patients
- HRT within 6 mths
- Pregnant and lactating women
- Patient with bleeding disorders
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06022237
Start Date
September 1 2023
End Date
August 30 2024
Last Update
September 1 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070