Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Renal Osteodystrophy; Chronic Renal Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT02147782

1RT1270,2010CB530400 (Other Grant/Funding Number)

Renal Osteodystrophy

Details and patient eligibility

About

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 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 6 patient groups

control

Description:

Healthy people from physical examination centers are recruited as controls.

CKD1

Description:

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

Description:

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

CKD3

Description:

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

CKD4

Description:

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

CKD5

Description:

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