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Ibandronate (drug) in Patients of Liver Cirrhosis With Hepatic Osteodystrophy

Phase 3
Conditions
Health Condition 1: K769- Liver disease, unspecified
Registration Number
CTRI/2023/09/057712
Lead Sponsor
Institute of Liver and Biliary Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Liver cirrhosis patients between 18 to 70 yrs with low risk esophageal varices and HOD (osteoporosis/osteopenia will be enrolled).

2.Patient and attendants willing to give informed consent

Exclusion Criteria

1.Age <18 years and > 70 years

2.Patients with prior history of fracture

3.History of upper GI bleed in last 2 months

4.Patients with post EVL ulcers

5.High risk esophageal varices or gastric varices without endoscopic treatment.

6.Active peptic ulcer

7.Severe vascular ectasia

8.Esophageal stricture

9.Achalasia

10.Creatinine clearance below 30ml/min

11.Malignancy(except HCC)

12.Hyperparathyroidism

13.Patients using NSAIDs, corticosteroids ,anticoagulants or ongoing alcohol beverages

14.Bisphosphonate hypersensitivity/Oral bisphosphonate within 12 months

15.Grade 2/3 ascites

16.Hepatic encephalopathy(Grade 3 &4)

17.Critically ill patients

18.Post LT patients

19.HRT within 6 mths

20.Pregnant and lactating women

21.Patient with bleeding disorders

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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