Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Renal Insufficiency, Renal Osteodystrophy

Participation Criteria
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Eligibility Criteria
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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: allergies 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>Healthy people from physical examination centers are recruited as controls. | |
| CKD1<br>with clinical one or more symptoms and signs of kidney injury listed as below： Urinary albumin ( urinary albumin excretion rate≥30 mg/24 h.albumin-creatinine ratio≥3mg/mmol) urinary sediments abnormality renal tubular lesions renal histological abnormalities abnormal structure showed by imaging history of renal transplantation GFR≥90（ml/min/1.73m²) | |
| CKD2<br>with clinical symptoms and signs of kidney injury, and 60<=GFR<=89（ml/min/1.73m²) | |
| CKD3<br>with clinical symptoms and signs of kidney injury, and 30<=GFR<=59（ml/min/1.73m²) | |
| CKD4<br>with clinical symptoms and signs of kidney injury, and 15<=GFR<=29（ml/min/1.73m²) | |
| CKD5<br>with clinical symptoms and signs of kidney injury, and GFR<15（ml/min/1.73m²) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone metabolism (bone mineral density and serum bone turnover biomarkers) | 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. | 1 day after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate） | CKD1-5 will be graded by glomerular filtration rate,and blood creatinine and urea nitrogen will be detected. | 1 day after enrollment | 
| Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD) | 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. | 1 day after enrollment | 
| MicroRNA array | 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. | 1 day after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function