Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Yongjun Wang, MD,PhD; Phone Number: 86-21-64385700; Email: yjwang88@hotmail.com
• Study Contact Backup: Name: Bing Shu, PhD; Phone Number: 86-21-64386239; Email: shubing523@hotmail.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Recruiting
      • Anhui province hospital of TCM
      • Contact: Shunjin Hu; Phone Number: 0551-62838661
      • Principal Investigator: Shunjin Hu
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Suspended
      • Jiangsu Province Hospital of TCM
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua hospital affiliated to Shanghai University of TCM
      • Contact: Xiaofeng Li, PhD; Phone Number: 86-21-64395700; Email: lixiaofeng0409@163.com
      • Principal Investigator: Xiaofeng Li
    • Shanghai, Shanghai, China, 200040
      • Completed
      • Huadong Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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 abnormalityrenal tubular lesionsrenal histological abnormalitiesabnormal structure showed by imaginghistory 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Baseline information （height, weight, sex）	1 day after enrollment

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Anhui Provincial Hospital; Huadong Hospital; Longhua Hospital
• Investigators: Principal Investigator: Yongjun Wang, Doctor, Shanhgai University of TCM

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Nutrition Disorders; Musculoskeletal Diseases; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Rickets; Vitamin D Deficiency; Hyperparathyroidism, Secondary; Hyperparathyroidism; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Kidney Disease-Mineral and Bone Disorder
• 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)