Chronic Renal Insufficiency, Renal Osteodystrophy
Conditions
Keywords
chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function
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.
Interventions
None listed
Sponsors
Anhui Provincial Hospital
Huadong Hospital
Longhua Hospital
Shanghai University of Traditional Chinese Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. 20-50 years old 2. chronic renal insufficiency (Control: normal kidney function; Case: CKD 1-5) 3. be willing to and be able to join in the study and signed informed consent 4. have not accepted systematical treatment on bone loss or osteoporosis
Exclusion criteria
1. allergies 2. secondary osteoporosis caused by other diseases. 3. postmenopausal women 4. mental illness or psychosis 5. patients with bone fracture and need surgery treatment 6. taking any medicine that will affect bone metabolism for a long time and can not stop 7. women during pregnant stage and breast-feed stage 8. with deformity or disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone metabolism (bone mineral density and serum bone turnover biomarkers) | 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
| Measure | Time frame | Description |
|---|---|---|
| Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate） | 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) | 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 | 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. |
Other
| Measure | Time frame |
|---|---|
| Baseline information （height, weight, sex） | 1 day after enrollment |
Countries
China
Contacts
Primary ContactYongjun Wang, MD,PhD
Backup ContactBing Shu, PhD
Outcome results
None listed