Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- extent of aortic and coronary artery calcification with and without the use of alendronate
研究概览
简要总结
Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can suppress the extent of coronary artery calcification in chronic hemodialysis patients. The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients.
详细描述
Study Design
The study is a prospective, randomized cross-over study. Fifty patients will be included. All participants are randomly allocated to either group 1 or group 2. Each group consists of 25 patients. Group 1 patients receive alendronate 70 mg once weekly in the first 24 weeks of the study, while group 2 patients receive the same dose of drug every week in the second 24 weeks. The extent of coronary artery and aortic calcification is evaluated by using multidetector spiral computed tomography, whereas bone mineral density is measured by dual-energy X-ray absorptiometry. Both examinations are performed at week 0, 24 and 48 for each participant. Serum level of calcium should be kept within normal limits and serum level of phosphorus should be kept below 6 mg/dl.
Administration of Alendronate
One tablet of alendronate (70 mg per tablet) should be swallowed by each patient once every week with water at least 30 minutes before breakfast, beverage or medication of the day during the treatment period. Patients must not lie down for at least 30 minutes after taking the drug.
Measurement of Coronary Artery and Aortic Calcification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received maintenance PD for more than 3 months at National Taiwan University Hospital,
- •Have high CPP level (≧50), and
- •Have chest X-ray proven aortic calcification or coronary artery calcification proven before.
排除标准
- •Patients are excluded if they have any one of the following conditions:
- •Had been hospitalized in recent 3 months due to severe comorbid diseases,
- •Are hypersensitive to alendronate or any of its components,
- •Have esophageal diseases
- •Are not able to stand or sit upright for 30 minutes,
- •Have refractory hypocalcemia, or
- •Patients who are pregnant.
结局指标
主要结局
extent of aortic and coronary artery calcification with and without the use of alendronate
bone mineral density with and without the use of alendronate
次要结局
- serum levels of calcium, phosphorus and parathyroid hormone