NCT05630768已完成4 期
A Multicenter, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
研究概览
简要总结
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Patients diagnosed with postmenopausal osteoporosis and administered denosumab for 1 year
排除标准
- •Any contraindication to risedronate
- •Those evaluated as inappropriate at the discretion of the investigator
研究组 & 干预措施
Actonel®
Experimental
Risedronate Sodium 35mg
干预措施: Risedronate Sodium 35 MG [Actonel] (Drug)
Actonel®
Experimental
Risedronate Sodium 35mg
干预措施: Calcium Vitamin D combination (Drug)
结局指标
主要结局
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
时间窗: 1 year
Percent change from baseline in lumbar spine bone mineral density (LS BMD) at 1 year (%)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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