NCT00493623已完成3 期
A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture 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
- 68
- 主要终点
- Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
研究概览
简要总结
This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women or men >30 years of age;
- •osteoporosis;
- •vertebral osteoporotic fracture in past 4 weeks;
- •fracture-related pain requiring analgesic treatment.
排除标准
- •non-menopausal women;
- •current treatment with another bisphosphonate;
- •current treatment with class III analgesics.
研究组 & 干预措施
1
Experimental
干预措施: ibandronate [Bonviva/Boniva] (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
时间窗: Day 7
次要结局
- Analgesic medication(1 month)
- Hospitalization(1 month)
- Percentage of patients with >=50% diminution of pain between day 0 and 7(Day 7)
- Pain control(Day 7 and 1 month)
- AEs and laboratory parameters(Throughout study)
研究者
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