JPRN-jRCT1051220150尚未招募Unknown
Equivalence Trial of Denosumab vs Zoledronate Following Romosozumab - DZR Trial
Takahashi Shinji0 个研究点目标入组 65 人开始时间: 2023年1月20日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 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
- •1. bone mineral density less than 2.5 SD and more than 1 fragility fracture
- •2. lumbar spine bone density less than -3.3 SD
- •3. more than 2 existing vertebral fractures
- •4. semi-quantitative evaluation method result of existing vertebral fracture is Genant grade 3.
- •5. judged to be necessary to improve surgical outcomes for osteoporosis
- •6. more than 7.5 mg of steroids (more than 3 months) and T-score <-2.5
- •Bone fracture despite treatment with bone resorption inhibitors
- •8. persistent loss of bone mineral density despite treatment with bone resorption inhibitors
- •Translated with www.DeepL.com/Translator (free version)
排除标准
- •1. patients with severe renal dysfunction (creatinine clearance <35 mL/min)
- •2. patients with a history of hypersensitivity to denosumab or bisphosphonates
- •3. patients with dehydration (high fever, severe diarrhea, vomiting, etc.)
- •4. patients with hypocalcemia
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