NCT00577850已完成1 期
Study to Determine the Pharmacokinetics of a Single 14C-labeled Intravenous Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose to Postmenopausal Women With Osteopenia or Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
研究概览
简要总结
The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol < 20 pg/mL and follicle stimulating hormone (FSH) > 40 IU/mL;
- •have osteopenia or osteoporosis (< 1.002 g/cm2 Lunar or < 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately < -1.5.
排除标准
- •any clinically significant out-of-range laboratory values and vital signs,
- •a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator
- •a known hypersensitivity to bisphosphonates
研究组 & 干预措施
1
Experimental
0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks
干预措施: risedronate (Drug)
2
Active Comparator
0.45 mg 14C-labeled alendronate, followed 7 days later with oral 70 mg of alendronate once a week for 52 weeks
干预措施: alendronate (Drug)
结局指标
主要结局
compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
时间窗: 28 days
次要结局
- to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.(52 weeks)
研究者
研究点 (2)
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