jRCT1041200081招募中不适用
EffecT of Romosozumab on bone mINeral densITY in hemodialysis Patents with Osteoporosis (TRINITY study)
未提供0 个研究点目标入组 100 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
- 招募中
- 入组人数
- 100
- 主要终点
- Rate of change in bone mineral density (BMD) at the lumber vertebra by dual-energy X-ray absorptiometry (DXA)
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
- 20age old over 至 100age old not（—）
- 性别
- All
入选标准
- •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
- •Patients on maintenance hemodialysis 3 times a week
- •Patients with more than one-year hemodialysis vintage
- •Patients who are judged stable
- •Older than 20 years and younger than 100 years
- •iPTH < 240 pg/ml at enrollment
- •corrected Ca >=8.4mg/dl at enrollment
- •Patients who are able to write informed consent
排除标准
- •Patients who have been prescribed romosozumab before
- •Bisphosphonate users within one year
- •Denosumab users within one year
- •Ischemic heart disease, stroke, lower limb amputation within one year
- •5.Steroid user (10mg/day or more in terms of PSL)
- •Active rheumatoid arthritis
- •Pregnant or breast feeding
- •Patients with severe complication, for instance cancer or severe infections
- •Inapporopriate for this study as judged by attending investigator
结局指标
主要结局
Rate of change in bone mineral density (BMD) at the lumber vertebra by dual-energy X-ray absorptiometry (DXA)
时间窗: 12 months
Rate of change in bone mineral density (BMD) at the lumber vertebra by dual-energy X-ray absorptiometry (DXA) after 12 months of treatment relative to baseline between romosozumab intervention group and control group
次要结局
- Rate of change in BMD at the proximal femur, lumber vertebra and femoral neck by DXA(6, 18, and 24 months)
- Change in BMD at the proximal femur, lumber vertebra and femoral neck by DXA(6, 12, 18, and 24 months)
- Rate of change and change in bone metabolic markers (P1NP,BAP,TRACP-5b)(1, 6, and 12 months)
- Rate of change and change in volume of thoracic spine and lunber verebra by 3D image analysis of CT under spinal conditions(12 and 24 months)
- Rate of change and change in height of thoracic spine and lunber verebra by 3D image analysis of CT under spinal conditions(12 and 24 months)
- Proportion of patients who do not have new fracture during intervention period
- Adverse events
- Dose of VitD
- Change of iPTH, Ca, P, ALP
研究者
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