Clinical Trial: Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages

Brief Summary: Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone loss, which is called renal osteodystrophy. Most of the previous studies focused on bone metabolism of patients in late stage of chronic renal insufficiency, especially those with chronic dialysis. In this study, bone metabolism of patients in different stages of chronic renal insufficiency will be observed to reveal the mechanism of development of renal osteodystrophy and provide clues for early intervention on renal osteodystrophy.

Detailed Summary: In this study, patients with chronic renal insufficiency (CKD1-5, defined by glomerular filtration rate，GFR) and healthy people as control will be recruited (50/group, total 300). Blood urea nitrogen, creatinine,lumbar and hip bone mineral density, bone turnover biochemical markers including serum total propeptide of type I procollagen（PINP）, bone alkaline phosphatase（BALP）, bone Gla-protein (BGP) and β-CrOSSlaps（β-CTX）, serum calcium and phosphorus and related regulators including fibroblast growth factor 23 (FGF23), 25-hydroxyl-Vitamin D （25-OH-VitD）, parathyroid hormone（PTH） will be detected. The relationship between kidney function and bone turnover, and the rules throughout the development process of renal osteodystrophy will be analysed.The micro ribonucleotide（miRNA）array will also be performed to screen the biomarkers of renal osteodystrophy in different stage.
Sponsor: Shanghai University of Traditional Chinese Medicine

Current Primary Outcome: bone metabolism (bone mineral density and serum bone turnover biomarkers) [ Time Frame: 1 day after enrollment ]

lumbar (L1-4 as well as total) and hip (neck, troch, inter and word's) bone mineral density will be recorded by dual energy X-ray absorptiometry. Serum bone turnover biomarkers including total PINP, BGP, BALP and β-CTx will be detected.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate） [ Time Frame: 1 day after enrollment ]
    CKD1-5 will be graded by glomerular filtration rate,and blood creatinine and urea nitrogen will be detected.
  • Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD) [ Time Frame: 1 day after enrollment ]
    Serum calcium and phosphorus will be detected and the calcium-phosphorus product will be calculated.Factors which are related with calcium and phosphorus including FGF23, PTH and 25-OH-VitD will be detected.
  • MicroRNA array [ Time Frame: 1 day after enrollment ]
    Blood plasma will be collected for microRNA array analysis to find specific biomarkers for each stage.We will also try to find biomarkers for better definitions of chronic renal insufficiency and renal osteodystrophy.


Original Secondary Outcome: Same as current

Information By: Shanghai University of Traditional Chinese Medicine

Dates:
Date Received: May 13, 2014
Date Started: October 2012
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016