NCT01376102已完成不适用
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Injection 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
- 657
- 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 injection administered in postmenopausal osteoporosis patients according to the prescribing information
研究设计
- 研究类型
- Observational
- 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 administered with BONVIVA(ibandronate) injection following the locally approved prescribing information Women diagnosed with postmenopausal osteoporosis. 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 injection Note: Subjects, who have experience of other bisphosphonates treatment, can be included.
- •Subjects who are indicated and administered of ibandronate injection according to the Prescribing Information in normal prescription use
排除标准
- •Considering the nature of this non-interventional PMS, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate injection 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 injection should not be administered to the following patients:
- •Patients with known hypersensitivity to ibandronate injection or to any of its excipients Uncorrected hypocalcemia Note: Ibandronate injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients.
研究组 & 干预措施
BONVIVA(ibandronate)
Patients administrated ibandronate injection with postmenopausal osteoporosis
干预措施: BONVIVA(ibandronate) injection (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 drug reaction after BONVIVA(ibandronate) injection administration(6 months)
- The number of serious adverse event after BONVIVA(ibandronate) injection administration(6 months)
- Effectiveness of BONVIVA(ibandronate) injection treatment(6 months)
研究者
研究点 (1)
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