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Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.

NCT06022237 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-09-01

No results posted yet for this study

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 frequently used. Intravenous infusions of bisphosphonates may cause prolonged arthralgia and myalgia whereas oral bisphosphonates may cause digestive mucosal damage causing dysphagia, esophagitis and ulcer. Such side effects have discouraged the prescription of oral bisphosphonates for patients of cirrhosis mainly due to risk of upper GI hemorrhage arising from esophageal variceal rupture.

All studies done in past with bisphosphonates are either open labelled RCT/ non- randomized control trial or have enrolled patients of primary biliary cirrhosis only.

So, there is a need to have double blind RCT assessing efficacy and safety of oral bisphosphonates in non-cholestatic liver cirrhosis.

In this study, we hypothesize that oral ibandronate significantly improves BMD in patients of liver cirrhosis \& is safe in patients with low risk esophageal varices. With this study, we aim to assess the efficacy and safety of oral ibandronate in patients of liver cirrhosis with hepatic osteodystrophy

Conditions

Interventions

DRUG

Ibandronate

Ibandronate 150 mg once monthly.

DRUG

Calcium

Calcium 500 mg twice daily

DRUG

Vitamin D3

Vitamin D3 - 1000 IU daily

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022237 on ClinicalTrials.gov