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

NCT06022237 | Unknown

• 1 other identifier: ILBS-Cirrhosis-61
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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

Hepatic Osteodystrophy; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in BMD at lumbar spine

  1 year

Secondary Outcomes (7)

• Change in BMD at femur neck

  1 year

• Incidence of UGI bleed in both arms

  1 year

• Change in bone turnover marker after 1 year of ibandronate

  1 year

• Association between T-score of DEXA scan at lumbar spine and femur neck with (Child-Turcotte-Pugh (CTP) score.

  1 year

• Association between T-score of DEXA scan at lumbar spine and femur neck with Model for End Stage Liver Disease score.

  1 year

Study Arms (2)

Ibandronate

EXPERIMENTAL

Ibandronate 150 mg once monthly in a supervised manner in front of student investigator and will be observed for 2 hours following ingestion. Patients will also receive Calcium 500mg BD and Vitamin D3 1000 mg OD

Drug: Ibandronate; Drug: Calcium; Drug: Vitamin D3

Placebo

ACTIVE COMPARATOR

Group B will receive placebo once monthly along with Calcium 500mg BD and Vitamin D3 1000 mg OD

Drug: Calcium; Drug: Vitamin D3

Interventions

Ibandronate DRUG

Ibandronate 150 mg once monthly.

Ibandronate

Calcium DRUG

Calcium 500 mg twice daily

Ibandronate; Placebo

Vitamin D3 DRUG

Vitamin D3 - 1000 IU daily

Ibandronate; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Ibandronic Acid; Calcium; Cholecalciferol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Dr Sudhir Kumar Verma, MD

CONTACT

01146300000; sudhirkgmu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 1, 2023
• Study Start: September 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)