PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Improvement in Bone Mineral Density on DEXA scan
研究概览
简要总结
Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of HOD in Indian population and its treatment outcome. The investigators aimed to determine prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone mineral density in patients with liver cirrhosis.
Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in female) and parathyroid hormone (PTH) along with routine investigations. Transient elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six months was given in patients with osteoporosis and DEXA scan repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18-70 years
- •Informed and written consent
排除标准
- •Chronic renal failure
- •Prolonged steroid use more than 3 months
- •Patients on immunosuppressive therapy
- •Primary hyperparathyroidism
- •Post menopausal women
- •Cushing's syndrome
- •HIV Co-infection
研究组 & 干预措施
Patients with osteoporosis
Treated with Ibandronic acid as per protocol
干预措施: Treated with Ibandronic acid as per protocol (Drug)
结局指标
主要结局
Improvement in Bone Mineral Density on DEXA scan
时间窗: 6 months
次要结局
- Incidence of new fractures(6 months)
研究者
Dr. Ashish Kumar
Associate Professor
Sir Ganga Ram Hospital
