NCT00384306已完成1 期
Investigation of the Side Effects of Orally Administered Glucocorticoids. An Open Label Study to Investigate the Effects of Orally Administered Prednisolone on Bone Metabolism in Patients With COPD.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline
研究概览
简要总结
The aim of this study is to establish associations between blood and urine markers of bone metabolism with histomorphometric changes (changes in the actual bone structure) resulting from short term oral prednisolone treatment in patients with COPD (chronic obstructive pulmonary disease).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females subjects must be unable to have children.
- •BMI 19 - 29.9
- •Non-smokers, ex-smokers or current light smokers (<10 cigarettes/day)
排除标准
- •High blood pressure
- •Other significant disease
- •Use of certain medications (to be decided by the investigator)
结局指标
主要结局
Mineral apposition rate Mineralising surface Eroded surface Bone formation rate Osteocalcin levels Serum and urinary deoxypyridinoline
时间窗: All measured with and without 3 weeks dosing with oral prednisolone
次要结局
- Pharmacokinetic measurements Bone structure and micro computer tomography of bone biopsies Biochemical markers of bone formation, bone break down and hormones(All measured with and without 3 weeks dosing with oral prednisolone)
研究者
研究点 (2)
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