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

Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057712
Enrollment
80
Registered
2023-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: 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 Cal

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Age 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

Design outcomes

Primary

MeasureTime frame
Change in BMD at lumbar spineTimepoint: 1 year—

Secondary

MeasureTime frame
Association between severity of HOD with severity of cirrhosisTimepoint: 1 year;Change in BMD at femur neckTimepoint: 1 year;Change in bone turnover marker after 1 year of ibandronateTimepoint: 1 year;Change in liver fraility index after 1 year of ibandronate therapyTimepoint: 1 year;Fracture rate after 1 year of ibandronate therapyTimepoint: 1 year;Incidence of UGI bleed in both armsTimepoint: 1 year—

Countries

India

Contacts

Public ContactDr Chitranshu vashishtha

Institute of Liver and Biliary Sciences

chitranshuv@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026