NCT05234047尚未招募不适用
Observational Study Evaluating the Effect of a Biotherapy Treatment (Anti- RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 主要终点
- Relative variation of coronary calcification scores after 24 months of follow-up
研究概览
简要总结
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:
- on coronary artery calcification scores evolution after 24 months of followup
- on abdominal aorta calcification scores evolution after 24 months of followup
- on bone mineral density (femoral T-score) at 24 months
- on bone mineral density evolution (femoral T-score) after 24 months of follow-up
- on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
- on parameters of bone remodelling after 24 months of follow-up
- on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
- the tolerance after 24 months of follow-up
详细描述
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab:
- on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up
- on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up
- on bone mineral density (femoral T-score) (by bone densitometry) at 24 months
- on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
- on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
- on parameters of bone remodelling after 24 months of follow-up
- on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
- the tolerance after 24 months of follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months
- •Osteoporosis
排除标准
- •Pregnancy or breastfeeeding female
- •Current corticoid treatment
- •PTH and Calcium outside the KDIGO guidelines
- •Adynamic bone disease suspicion
- •Cancer or myeloma
- •Serious hepatic cytolysis
- •Serious dental troubles
- •Positive HIV serology
- •Hypersensibility to active substance or one of excipients of denosumab
结局指标
主要结局
Relative variation of coronary calcification scores after 24 months of follow-up
时间窗: 24 months after inclusion
次要结局
- Relative variation of abdominal aorta calcification scores after 24 months of follow-up(24 months after inclusion)
- Variation of phosphorus at 6, 12, 18 et 24 months of follow-up(6, 12, 18 and 24 months after inclusion)
- Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)(24 months after inclusion)
- Relative variation of whole body bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)(24 months after inclusion)
- Variation of calcium at 6, 12, 18 and 24 months of follow-up(6, 12, 18 and 24 months after inclusion])
- Variation of inflammation at 6, 12, 18 et 24 months of follow-up(6, 12, 18 and 24 months after inclusion)
- Relative variation of radius bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)(24 months after inclusion)
- Morbi-mortality at 24 months of follow-up(24 months after inclusion])
- Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)(24 months after inclusion)
- Variation of bone remodeling at 6, 12, 18 et 24 months of follow-up(6, 12, 18 and 24 months after inclusion)
- Adverse events occuring during the entire study(24 months after inclusion])
研究者
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