Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in BMD at lumbar spine
研究概览
简要总结
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
详细描述
Hypothesis : Oral ibandronate 150 mg once monthly significantly improves BMD in patients of liver cirrhosis with hepatic osteodystrophy by decreasing bone resorption & is safe in patients with low risk esophageal varices.
Methodology:
Study population: All the consecutive patients with liver cirrhosis attending department of Hepatology will be evaluated for inclusion criteria. The diagnosis of cirrhosis will be confirmed either by liver biopsy or associated clinical, radiological and endoscopic findings compatible with cirrhosis and PH.
All enrolled patients will undergo detailed evaluation by thorough history ,clinical examination and relevant laboratory investigations.
All cirrhotic patients will be subjected to upper GI endoscopy. Patients with low risk esophageal varices(grade I and II without red-color signs) and low risk GOV-1/GOV2 will be subjected to DEXA scan to measure BMD at femur neck and lumbar spine. Patient with grade II and III varices with RCS will be enrolled only after EVL after 6-8 weeks until varices achieve a low risk status described as eradicated/grade I & II varices without RCS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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
干预措施: Ibandronate (Drug)
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
干预措施: Calcium (Drug)
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
干预措施: Vitamin D3 (Drug)
Placebo
Group B will receive placebo once monthly along with Calcium 500mg BD and Vitamin D3 1000 mg OD
干预措施: Calcium (Drug)
Placebo
Group B will receive placebo once monthly along with Calcium 500mg BD and Vitamin D3 1000 mg OD
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Change in BMD at lumbar spine
时间窗: 1 year
次要结局
- Change in BMD at femur neck(1 year)
- Incidence of UGI bleed in both arms(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)
- 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)
- Fracture rate after 1 year of ibandronate therapy(1 year)
- Change in liver fraility index after 1 year of ibandronate therapy(1 year)