JPRN-jRCT1080222429已完成未知
36-month Special Drug Use Surveillance on Frequency of Bone Fractures with Benet 75 mg Tablets
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 579
研究概览
简要总结
In conclusion, no new problem of Benet was detected in terms of the safety or efficacy in clinical settings. In addition, as high as 83.24% to 95.38% of patients took the drug as instructed by a physician from the start of Benet treatment to the 36th dose (3 years), and the median dosing interval between two consecutive doses was 30.0 to 31.0 days, showing a good treatment status. Refer to summary of the special drug use surveillance in "Secondary Outcome Measures" section for others.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Osteoporosis patients who meet all the following criteria:
- •1. Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
- •2. Male and postmenopausal female patients aged 50 years or older
- •3. Ambulatory outpatients
排除标准
- 未提供
研究者
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