Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- bone metabolism (bone mineral density and serum bone turnover biomarkers)
Study Overview
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 Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •20-50 years old
- •chronic renal insufficiency (Control: normal kidney function; Case: CKD 1-5)
- •be willing to and be able to join in the study and signed informed consent
- •have not accepted systematical treatment on bone loss or osteoporosis
Exclusion Criteria
- •secondary osteoporosis caused by other diseases.
- •postmenopausal women
- •mental illness or psychosis
- •patients with bone fracture and need surgery treatment
- •taking any medicine that will affect bone metabolism for a long time and can not stop
- •women during pregnant stage and breast-feed stage
- •with deformity or disability
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- MicroRNA array(1 day after enrollment)
- Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD)(1 day after enrollment)
- Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate）(1 day after enrollment)
Investigators
Bing Shu
Associate Professor
Shanghai University of Traditional Chinese Medicine