JPRN-jRCT1041200081招募中未知
EffecT of Romosozumab on bone mINeral densITY in hemodialysis Patents with Osteoporosis - TRINITY study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
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
- >= 20age old 至 < 100age old（—）
- 性别
- All
入选标准
- •1. Patients with osteoporosis on high risk fracture
- •1.1 a bone mineral density T score of -2.5SD or less and vulnerable fracture 12 months before entry
- •1.2 a bone mineral density T score of -3.3SD or less at the lumber vertebra
- •1.3 history of more than two vertebral fractures
- •1.4 history of grade 3 vertebral fracture by semiquantitative methods
- •2. Patients on maintenance hemodialysis 3 times a week
- •3. Patients with more than one-year hemodialysis vintage
- •4. Patients who are judged stable
- •5. Older than 20 years and younger than 100 years
- •6. iPTH < 240 pg/ml at enrollment
- •7. corrected Ca >=8.4mg/dl at enrollment
- •8. Patients who are able to write informed consent
排除标准
- •1. Patients who have been prescribed romosozumab before
- •2. Bisphosphonate users within one year
- •3. Denosumab users within one year
- •4. Ischemic heart disease, stroke, lower limb amputation within one year
- •5.Steroid user (10mg/day or more in terms of PSL)
- •6. Active rheumatoid arthritis
- •7. Pregnant or breast feeding
- •8. Patients with severe complication, for instance cancer or severe infections
- •9. Inapporopriate for this study as judged by attending investigator
研究者
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