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Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

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ClinicalTrials.gov Identifier: NCT02147782
Recruitment Status : Recruiting
First Posted : May 28, 2014
Last Update Posted : April 18, 2018
Sponsor:
Collaborators:
Anhui Provincial Hospital
Huadong Hospital
Longhua Hospital
Information provided by (Responsible Party):
Bing Shu, 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.

Condition or disease
Chronic Renal Insufficiency 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 Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages
Study Start Date : October 2012
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
control
Healthy people from physical examination centers are recruited as controls.
CKD1
  1. with clinical one or more symptoms and signs of kidney injury listed as below:

    1. Urinary albumin ( urinary albumin excretion rate≥30 mg/24 h.albumin-creatinine ratio≥3mg/mmol)
    2. urinary sediments abnormality
    3. renal tubular lesions
    4. renal histological abnormalities
    5. abnormal structure showed by imaging
    6. history of renal transplantation
  2. 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)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Baseline information (height, weight, sex) [ Time Frame: 1 day after enrollment ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma of cases and controls


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cases groups (CKD-5) are recruited from inpatients and outpatients in the 4 centers.

Controls are recruited from community samples and physical examination population.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147782


Contacts
Contact: Yongjun Wang, MD,PhD 86-21-64385700 yjwang88@hotmail.com
Contact: Bing Shu, PhD 86-21-64386239 shubing523@hotmail.com

Locations
China, Anhui
Anhui Province Hospital of TCM Recruiting
Hefei, Anhui, China, 230031
Contact: Shunjin Hu    0551-62838661      
Principal Investigator: Shunjin Hu         
China, Jiangsu
Jiangsu Province Hospital of TCM Suspended
Nanjing, Jiangsu, China
China, Shanghai
Longhua hospital affiliated to Shanghai University of TCM Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaofeng Li, PhD    86-21-64395700    lixiaofeng0409@163.com   
Principal Investigator: Xiaofeng Li         
Huadong Hospital Affiliated to Fudan University Completed
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Anhui Provincial Hospital
Huadong Hospital
Longhua Hospital
Investigators
Principal Investigator: Yongjun Wang, Doctor Shanhgai University of TCM

Responsible Party: Bing Shu, Research Asistant, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02147782     History of Changes
Other Study ID Numbers: Renal Osteodystrophy
1RT1270,2010CB530400 ( Other Grant/Funding Number: Innovative Research Team in University of Ministry of Education of China, 973 Project )
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Bing Shu, Shanghai University of Traditional Chinese Medicine:
chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Kidney Disease-Mineral and Bone Disorder
Kidney Diseases
Urologic Diseases
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases