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
- 发起方
- Bayer
- 入组人数
- 411
- 主要终点
- Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara
研究概览
简要总结
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who received Wellnara for postmenopausal osteoporosis
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
Drug (incl. Placebo)
干预措施: E2/LNG oral (Wellnara, BAY86-5029) (Drug)
结局指标
主要结局
Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara
时间窗: After Wellnara administration, up to 3 years
次要结局
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnara(At baseline and after Wellnara administration, up to 3 years)
- Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse(At baseline and after Wellnara treatment, up to 3 years)
研究者
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