Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy.
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ClinicalTrials.gov Identifier: NCT06022237 |
Recruitment Status :
Not yet recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatic Osteodystrophy Liver Cirrhosis | Drug: Ibandronate Drug: Calcium Drug: Vitamin D3 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | August 30, 2024 |
Estimated Study Completion Date : | August 30, 2024 |
Arm | Intervention/treatment |
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Experimental: Ibandronate
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
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Drug: Ibandronate
Ibandronate 150 mg once monthly. Drug: Calcium Calcium 500 mg twice daily Drug: Vitamin D3 Vitamin D3 - 1000 IU daily |
Active Comparator: Placebo
Group B will receive placebo once monthly along with Calcium 500mg BD and Vitamin D3 1000 mg OD
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Drug: Calcium
Calcium 500 mg twice daily Drug: Vitamin D3 Vitamin D3 - 1000 IU daily |
- Change in BMD at lumbar spine [ Time Frame: 1 year ]
- Change in BMD at femur neck [ Time Frame: 1 year ]
- Incidence of UGI bleed in both arms [ Time Frame: 1 year ]
- Change in bone turnover marker after 1 year of ibandronate [ Time Frame: 1 year ]
- Association between T-score of DEXA scan at lumbar spine and femur neck with (Child-Turcotte-Pugh (CTP) score. [ Time Frame: 1 year ]
- Association between T-score of DEXA scan at lumbar spine and femur neck with Model for End Stage Liver Disease score. [ Time Frame: 1 year ]
- Fracture rate after 1 year of ibandronate therapy [ Time Frame: 1 year ]
- Change in liver fraility index after 1 year of ibandronate therapy [ Time Frame: 1 year ]
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022237
Contact: Dr Sudhir Kumar Verma, MD | 01146300000 | sudhirkgmu@gmail.com |
India | |
Institute of Liver & Biliary Sciences (ILBS) | |
New Delhi, Delhi, India, 110070 | |
Contact: Dr Sudhir Kumar Verma, MD 01146300000 sudhirkgmu@gmail.com |
Responsible Party: | Institute of Liver and Biliary Sciences, India |
ClinicalTrials.gov Identifier: | NCT06022237 |
Other Study ID Numbers: |
ILBS-Cirrhosis-61 |
First Posted: | September 1, 2023 Key Record Dates |
Last Update Posted: | September 1, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases Vitamin D Cholecalciferol |
Ibandronic Acid Calcium Vitamins Micronutrients Physiological Effects of Drugs Calcium-Regulating Hormones and Agents Bone Density Conservation Agents |