Non-randomized Prospective Study on the Effect of Antiviral Therapy With Peginterferon Alfa-2a and Ribavirin on Bone Mineral Density and Metabolism in Patients With Chronic Viral Hepatitis C Genotype 1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin
研究概览
简要总结
One single study has suggested that bone mineral density (BMD) is reduced in patients with non-cirrhotic chronic viral hepatitis C. Antiviral combination therapy with standard interferon and ribavirin may further decrease BMD. The aim of this study is to systematically investigate the effect of chronic hepatitis C genotype 1 infection alone and current standard therapy with peginterferon alfa-2a/ribavirin on BMD and bone metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •proven chronic hepatitis C
- •aged between 18 and 65
- •male patients
排除标准
- •high grade liver fibrosis (Grade 3 - 4)
- •renal disease
- •hyperparathyroidism
- •hypogonadism
- •malignant disease
- •use of any other drug known to effect bone mineral metabolism
- •use of alcohol
- •organ transplant
- •any form of thyroid disease
- •any medical condition known to be associated with bone loss
研究组 & 干预措施
Treatment
Chronic hepatitis C patients on standard antiviral therapy with peginterferon alfa-2a and ribavirin
干预措施: peginterferon alfa-2a and ribavirin (Drug)
结局指标
主要结局
Change of the bone mineral density of the lumbar spine and right hip measured by DEXA in patients with chronic hepatitis C with or without antiviral combination treatment with peginterferon and ribavirin
时间窗: 96 weeks
次要结局
- Change in markers of bone formation and resorption over time during antiviral therapy and after cessation of therapy.(96 weeks)