Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

NCT02147782 | Unknown DMC

• 2 other identifiers: Renal Osteodystrophy1RT1270,2010CB530400
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Renal Insufficiency; Renal Osteodystrophy

Keywords

chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate）

  1 day after enrollment

• Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD)

  1 day after enrollment

• MicroRNA array

  1 day after enrollment

Other Outcomes (1)

• Baseline information （height, weight, sex）

  1 day after enrollment

Study Arms (6)

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)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• years old
• chronic renal insufficiency (Control: normal kidney function; Case: CKD 1-5)
• be willing to and be able to join in the study and signed informed consent
• have not accepted systematical treatment on bone loss or osteoporosis

You may not qualify if:

• allergies
• secondary osteoporosis caused by other diseases.
• postmenopausal women
• mental illness or psychosis
• patients with bone fracture and need surgery treatment
• taking any medicine that will affect bone metabolism for a long time and can not stop
• women during pregnant stage and breast-feed stage
• with deformity or disability

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Anhui Provincial Hospital: collaborator
• Huadong Hospital: collaborator
• Longhua Hospital: collaborator

Study Sites (4)

Anhui Province Hospital of TCM

Hefei, Anhui, 230031, China

RECRUITING

Jiangsu Province Hospital of TCM

Nanjing, Jiangsu, China

SUSPENDED

Longhua hospital affiliated to Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

COMPLETED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma of cases and controls

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Yongjun Wang, Doctor

  Shanhgai University of TCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongjun Wang, MD,PhD

CONTACT

86-21-64385700; yjwang88@hotmail.com

Bing Shu, PhD

CONTACT

86-21-64386239; shubing523@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 28, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

CN (4)