NCT00144456已完成3 期
A Prospective, Randomized, Double-blind Study to Compare the Effect of ED-71 With That of Alfacalcidol on Fracture Incidence in Osteoporotic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,056
- 主要终点
- Incidences of vertebral fracture
研究概览
简要总结
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoporotic patients who meet any of the following condition:
- •with at least one fragility fracture,
- •above 70 year-old with bone mineral density below 70% young adult mean,
- •with bone mineral density below 60% young adult mean
- •Women three years or more after menopause or men
排除标准
- •Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis
- •A history or suspicion of active urolithiasis at any time
- •Use of bisphosphonates in the past 12 months
- •Use of medications known to affect bone in the past 2 months
- •Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
研究组 & 干预措施
1
Experimental
干预措施: ED-71 (Drug)
1
Experimental
干预措施: Alfacalcidol placebo (Drug)
2
Active Comparator
干预措施: Alfacalcidol (Drug)
2
Active Comparator
干预措施: ED-71 placebo (Drug)
结局指标
主要结局
Incidences of vertebral fracture
时间窗: throughout study
次要结局
- Changes of Lumbar Spine and total hip bone mineral density(throughout study)
研究者
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