jRCT1051220150尚未招募不适用
Equivalence Trial of Denosumab vs Zoledronate Following Romosozumab (DZR Trial)
未提供0 个研究点目标入组 65 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 50age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients on romosozumab for osteoporosis who are 50 years of age or older and have one of the following criteria at the time of starting romosozumab
- •bone mineral density less than 2.5 SD and more than 1 fragility fracture
- •lumbar spine bone density less than -3.3 SD
- •more than 2 existing vertebral fractures
- •semi-quantitative evaluation method result of existing vertebral fracture is Genant grade
- •judged to be necessary to improve surgical outcomes for osteoporosis
- •more than 7.5 mg of steroids (more than 3 months) and T-score <-2.5
- •Bone fracture despite treatment with bone resorption inhibitors
- •persistent loss of bone mineral density despite treatment with bone resorption inhibitors
- •Translated with www.DeepL.com/Translator (free version)
排除标准
- •patients with severe renal dysfunction (creatinine clearance <35 mL/min)
- •patients with a history of hypersensitivity to denosumab or bisphosphonates
- •patients with dehydration (high fever, severe diarrhea, vomiting, etc.)
- •patients with hypocalcemia
结局指标
主要结局
-
Bone mineral density (Lumbar spine, Total hip)
次要结局
未报告次要终点
研究者
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