NCT00545480已完成4 期
A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 596
- 主要终点
- Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
研究概览
简要总结
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
- •>55 years of age;
- •naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months.
排除标准
- •inability to stand or sit in an upright position for at least 60 minutes;
- •hypersensitivity to bisphosphonates;
- •treatment with other drugs affecting bone metabolism;
- •history of major upper gastrointestinal disease.
研究组 & 干预措施
1
Experimental
干预措施: ibandronate [Bonviva/Boniva] (Drug)
2
Active Comparator
干预措施: ibandronate [Bonviva/Boniva] (Drug)
结局指标
主要结局
Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group
时间窗: 12 months
次要结局
- Differences between groups in persistence(6 months)
- QoL and patient satisfaction(6 and 12 months)
研究者
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