Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

Overview

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.

Full Title of Study: “Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020

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.

Arms, Groups and Cohorts

  • control
    • Healthy people from physical examination centers are recruited as controls.
  • CKD1
    • 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
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Kidney function (blood creatinine and urea nitrogen,glomerular filtration rate)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shanghai University of Traditional Chinese Medicine
  • Collaborator
    • Anhui Provincial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bing Shu, Associate Professor – Shanghai University of Traditional Chinese Medicine
  • Overall Official(s)
    • Yongjun Wang, Doctor, Principal Investigator, Shanhgai University of TCM
  • Overall Contact(s)
    • Yongjun Wang, MD,PhD, 86-21-64385700, yjwang88@hotmail.com

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