NCT00545090已完成4 期
An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 561
- 主要终点
- SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
研究概览
简要总结
This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients responding to oral monthly Bonviva during the BonAdAsia study;
- •willing to continue Bonviva treatment for a further 6 months.
排除标准
- •none specified.
研究组 & 干预措施
1
Experimental
干预措施: ibandronate [Bonviva/Boniva] (Drug)
结局指标
主要结局
SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
时间窗: Throughout study
次要结局
未报告次要终点
研究者
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