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| ID | Type | Description | Link |
|---|---|---|---|
| 1RT1270,2010CB530400 | Other Grant/Funding Number | Innovative Research Team in University of Ministry of Education of China, 973 Project |
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| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
| Huadong Hospital | OTHER |
| Longhua Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Healthy people from physical examination centers are recruited as controls. | ||
| CKD1 |
| ||
| CKD2 | with clinical symptoms and signs of kidney injury, and 60<=GFR<=89（ml/min/1.73m²) | ||
| CKD3 | with clinical symptoms and signs of kidney injury, and 30<=GFR<=59（ml/min/1.73m²) | ||
| CKD4 | with clinical symptoms and signs of kidney injury, and 15<=GFR<=29（ml/min/1.73m²) | ||
| CKD5 | with clinical symptoms and signs of kidney injury, and GFR<15（ml/min/1.73m²) |
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| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline information （height, weight, sex） | 1 day after enrollment |
Inclusion Criteria:
Exclusion Criteria:
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Cases groups (CKD-5) are recruited from inpatients and outpatients in the 4 centers.
Controls are recruited from community samples and physical examination population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjun Wang, MD,PhD | Contact | 86-21-64385700 | yjwang88@hotmail.com | |
| Bing Shu, PhD | Contact | 86-21-64386239 | shubing523@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, Doctor | Shanhgai University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Province Hospital of TCM | Recruiting | Hefei | Anhui | 230031 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Serum and plasma of cases and controls
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 |
| Jiangsu Province Hospital of TCM | Suspended | Nanjing | Jiangsu | China |
| Longhua hospital affiliated to Shanghai University of TCM | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Huadong Hospital Affiliated to Fudan University | Completed | Shanghai | Shanghai Municipality | 200040 | China |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |