跳至主要内容
临床试验/NCT07193056
NCT07193056招募中不适用

Chronic Kidney Disease -Mineral and Bone Disorder, The CPH-MBD Cohort

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年1月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Difference in time to first fracture between patients with normal bone turnover and low bone turnover based on bone turnover markers at baseline

研究概览

简要总结

Persons with chronic kidney disease (CKD) have a 3-fold increased risk of bone fracture and a 10-fold increased risk of cardiovascular disease than the general population. These increased risks are related to the disturbances in the mineral metabolism, and this clinical entity is termed Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD).

The overall aim of the present project is to explore factors that may predict or associate with the development of bone and cardiovascular disease in patients with CKD and hopefully provide insight into underlying mechanisms and pathophysiological pathways for future treatment and prevention.

In a sub study investigators aim to explore the calcium and phosphate balance in patients with CKD and describe how these associate with each other as well as with kidney function (eGFR).

详细描述

Chronic kidney disease (CKD) is a chronic condition where the excretory kidney function (estimated glomerular filtration rate (eGFR)) is reduced and/or markers of kidney damage is present (often presented as albuminuria). CKD is classified into stages CKD G1-5 according the severity of the reduction in eGFR.

The prevalence of CKD is increasing world-wide, partly explained by the increase in the ageing population and prevalence of diabetes3. In Denmark, the prevalence of CKD in the population is 4-8% depending on the applied algorithm. CKD is a devastating disease both due to the risk of kidney failure and thereby the need for dialysis or transplantation, but also because the presence of CKD increases the risk of bone fracture, cardiovascular disease and mortality.

Disturbances in the mineral metabolism, including hyperphosphatemia and hyperparathyroidism develops as kidney function declines. These disturbances are closely related to the increased risk of bone and cardiovascular disease, and this relation has been gathered since 2009 in the clinical entity named Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD).

The bone pathology in patients with CKD, named renal osteodystrophy, can be classified by the TMV classification. The TMV classification describes the bone Turnover, the bone Mineralization and the bone Volume, which may all be disturbed in renal osteodystrophy.

Per see, disturbances in the bone pathology, especially in the bone turnover is considered harmful to the bone strength. However, no studies have addressed if disturbances in the bone turnover increases the risk of bone fracture. This is the primary aim of the present study.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Age ≥18 years
  • CKD stage 4-5nonD (eGFR ≤ 29 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition

排除标准

  • 未提供

研究组 & 干预措施

CPH-MBD cohort

Participants will be followed-up for 25 years after inclusion. Bone fractures, cardiovascular events, progression of kidney disease, end-stage kidney disease and death will be collected through linkage with registries during follow-up.

There is no intervention in this study.

Detailed dietary assessment

From the CPH-MBD cohort we invite 50 participants to complete a dietary assessment to obtain more accurate information about their calcium and phosphate intake.

结局指标

主要结局

Difference in time to first fracture between patients with normal bone turnover and low bone turnover based on bone turnover markers at baseline

时间窗: 25 years

次要结局

  • Time to fracture(25 years)
  • Time to cardiovascular event(25 years)
  • Progression in kidney disease(25 years)
  • Time to end-stage kidney disease(25 years)
  • Time to death(25 years)
  • Time to fracture(25 years)
  • Time to cardiovascular event(25 years)
  • Progression in kidney disease(25 years)
  • Time to end-stage kidney disease(25 years)
  • Time to death(25 years)
  • Intake of phosphate(Daily (for the first three days after inclusion))
  • Intake of calcium(Daily (for the first three days after inclusion))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Freja Stæhr Hassager

Medical doctor

Herlev and Gentofte Hospital

研究点 (1)

Loading locations...

相似试验