NCT00447915已完成3 期
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -
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
- 1,265
- 试验地点
- 4
- 主要终点
- Incidence of vertebral fracture
研究概览
简要总结
To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.
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
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with fragile bone fracture
- •Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
- •Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
- •Ambulatory
排除标准
- •Patients with disease lowering bone volume secondarily (secondary osteoporosis)
- •Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
- •Patient with disorder delaying the passage of food through esophagus
研究组 & 干预措施
1
Experimental
干预措施: ibandronic acid 0.5mg (Drug)
1
Experimental
干预措施: RIS placebo (Drug)
1
Experimental
干预措施: Calcium and Vitamine D3 (Dietary Supplement)
2
Experimental
干预措施: RIS placebo (Drug)
2
Experimental
干预措施: 1.0mg ibandronic acid (Drug)
2
Experimental
干预措施: Calcium and Vitamine D3 (Dietary Supplement)
3
Active Comparator
干预措施: ibandronic acid placebo (Drug)
3
Active Comparator
干预措施: 2.5mg RIS (Drug)
3
Active Comparator
干预措施: Calcium and Vitamine D3 (Dietary Supplement)
结局指标
主要结局
Incidence of vertebral fracture
时间窗: 36 months
次要结局
- Change of bone density of lumbar spine and proximal part of femur from baseline(36 months)
- Change of bone absorption marker from baseline(36 months)
- Change of bone formation marker from baseline(36 months)
研究者
研究点 (4)
Loading locations...
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