NCT02792413终止4 期
Randomized Controlled Study Evaluating the Effect of a Biotherapy Treatment (Anti-RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 9
- 主要终点
- Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
研究概览
简要总结
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:
- 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 coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
- on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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 old osteoporotic chronic kidney disease females the effect of denosumab:
- 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 coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) after 24 months of follow-up
- on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient of 65 years or older
- •Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
- •Patient with osteoporosis (history of bone fracture or T-scoring < -2.5 SD)
- •PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.
排除标准
- •Cinacalcet treatment
- •Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines
- •Suspicion of lower bone remodeling
- •Hypersensibility to active substance or one of excipients of denosumab
- •Patient with a cancer or myeloma
- •Patient with severe heaptic cytolysis
- •Patients with severe teeth problems
- •Patient positive for HIV
- •Patient involved in another biomedical research
- •Vulnerable patients (protected by the law, under guardianship, deprived of freedom)
研究组 & 干预措施
Denosumab
Experimental
Denosumab 60 mg, subcutaneous injection every 6 months for 24 months
干预措施: Denosumab (Drug)
Placebo
Placebo Comparator
NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months
干预措施: NaCl (placebo) (Drug)
结局指标
主要结局
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
时间窗: 24 months after inclusion
次要结局
- Morbi-mortality at 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 abdominal aorta calcification scores after 24 months of follow-up(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)
- Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)(24 months after inclusion)
- Relative variation of coronary calcification scores after 24 months of follow-up(24 months after inclusion)
- Adverse events occuring during the entire study(24 months after inclusion)
研究者
研究点 (9)
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