NCT01381393已完成不适用
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 659
- 试验地点
- 1
- 主要终点
- The number of adverse event after ibandronate administration
研究概览
简要总结
This is an open label, multi-centre, non-interventional post-marketing surveillance.
详细描述
This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ibandronate administered in Korean patients according to the prescribing information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All subjects must satisfy the following criteria at study entry:
- •Subjects diagnosed with osteoporosis in postmenopausal women.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- •Subjects with no experience of treatment using ibandronate.
- •Subjects who are administered of ibandronate in normal prescription use
排除标准
- •Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate following the locally approved Prescribing Information.
- •The following criteria should be checked at the time of study entry.
- •According to contraindication on the prescribing information, ibandronate should not be administered to the following patients:
- •Patients with known hypersensitivity to ibandronate or to any of its excipients
- •Uncorrected hypocalcemia
- •Inability to stand or sit upright for at least 60 minutes
研究组 & 干预措施
Ibandronate
The subjects with osteoporosis in postmenopausal women
干预措施: Ibandronate (Drug)
结局指标
主要结局
The number of adverse event after ibandronate administration
时间窗: 6 months
次要结局
- The number of unexpected adverse events after ibandronate administration(6 months)
- The number of serious adverse events after ibandronate administration(6 months)
研究者
研究点 (1)
Loading locations...
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