跳至主要内容
临床试验/CTRI/2023/03/051127
CTRI/2023/03/051127招募中不适用

A study of determinants of low bone mineral density in patients with advanced chronic kidney disease

King Edward Memorial Hospital, Pune1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2023年10月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
340
试验地点
1
主要终点
Prevalence of low BMD in patients with advanced chronic kidney disease

研究概览

简要总结

Advancedstages of chronic kidney disease (CKD) are associated with abnormalities inbone and mineral health of the patient. They may manifest as decreased bonemineral density, abnormalities in bone volume, calcification of vascular and/orsoft tissues. Low bone mineral density (BMD) as measured by dual-energy X-rayabsorptiometry, predicts the risk of fragility fracture. Skeletal fractures areimportant cause of CKD-related morbidity.

Despiteof high prevalence of decreased bone mineral density in CKD, diagnosis and roleof bone mineral density remain understudied in India. Further, the studies areneeded to determine the factors associated with low BMD.

Inthis study, we will measure BMD by DEXA scan and determine the prevalence oflow BMD in advanced CKD in Indian population. With the use of statisticaltests, we will observe relationship between low BMD and Stage of CKD,biochemical markers, age, gender and BMI and various other determinants of low BMD.

Thiscross-sectional observational study will be carried out over period of 18months and will include adult patients with advanced CKD, admitted in wards orseen in outpatient of KEM Hospital, Pune. Post renal transplant patients,pregnant, patients with previous spine surgery and those on osteoporosistherapy will be excluded.

Weexpect to determine prevalence of low BMD in advanced CKD in Indian populationand establish relationship between low BMD with stage of CKD, biochemicalmarkers and demographical parameters which will help in early suspicion anddiagnosis of CKD-MBD and effect of modifications in determinants on clinicaloutcome.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with age >18 years with CKD stage 4 and 5 2.Patients with CKD 5D on Dialysis (PD and HD) started within last 12 months.

排除标准

  • 1.Post-renal transplant patients 2.Pregnancy 3.Patients with previous spine surgeries 4.Patients on osteoporosis therapy 5.Use of corticosteroids within last 6 months.

结局指标

主要结局

Prevalence of low BMD in patients with advanced chronic kidney disease

时间窗: 6 months

次要结局

  • factors associated with low BMD(18 months)

研究者

发起方
King Edward Memorial Hospital, Pune
申办方类型
Private hospital/clinic

研究点 (1)

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