Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

• Conditions: Chronic Renal Insufficiency; Renal Osteodystrophy

• Registration Number: NCT02147782
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-23
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (4)

Huadong Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

Anhui Province Hospital of TCM; 🇨🇳 Hefei, Anhui, China

Longhua hospital affiliated to Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China

Jiangsu Province Hospital of TCM; 🇨🇳 Nanjing, Jiangsu, China