Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

NCT ID: NCT02147782

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Renal Insufficiency Renal Osteodystrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

Healthy people from physical examination centers are recruited as controls.

No interventions assigned to this group

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)

No interventions assigned to this group

CKD2

with clinical symptoms and signs of kidney injury, and 60\<=GFR\<=89(ml/min/1.73m²)

No interventions assigned to this group

CKD3

with clinical symptoms and signs of kidney injury, and 30\<=GFR\<=59(ml/min/1.73m²)

No interventions assigned to this group

CKD4

with clinical symptoms and signs of kidney injury, and 15\<=GFR\<=29(ml/min/1.73m²)

No interventions assigned to this group

CKD5

with clinical symptoms and signs of kidney injury, and GFR\<15(ml/min/1.73m²)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Huadong Hospital

OTHER

Sponsor Role collaborator

Longhua Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bing Shu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongjun Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanhgai University of TCM

Locations

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Anhui Province Hospital of TCM

Hefei, Anhui, China

Site Status RECRUITING

Jiangsu Province Hospital of TCM

Nanjing, Jiangsu, China

Site Status SUSPENDED

Longhua hospital affiliated to Shanghai University of TCM

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status COMPLETED

Countries

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China

Central Contacts

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Yongjun Wang, MD,PhD

Role: CONTACT

86-21-64385700

Bing Shu, PhD

Role: CONTACT

86-21-64386239

Facility Contacts

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Shunjin Hu

Role: primary

0551-62838661

Xiaofeng Li, PhD

Role: primary

86-21-64395700

Other Identifiers

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1RT1270,2010CB530400

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Renal Osteodystrophy

Identifier Type: -

Identifier Source: org_study_id

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