Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

Chronic Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147782
• Other study ID #: Renal Osteodystrophy
• Secondary ID: 1RT1270,2010CB53
• Status: Recruiting
• Start date: October 2012
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yongjun Wang, MD,PhD
• Phone: 86-21-64385700
• Email: yjwang88[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease-Mineral and Bone Disorder
• Chronic Renal Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Renal Osteodystrophy

Locations

Country	Name	City	State
China	Anhui Province Hospital of TCM	Hefei	Anhui
China	Jiangsu Province Hospital of TCM	Nanjing	Jiangsu
China	Huadong Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Longhua hospital affiliated to Shanghai University of TCM	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Anhui Provincial Hospital, Huadong Hospital, Longhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline information (height, weight, sex)		1 day after enrollment
Primary	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 ß-CTx will be detected.	1 day after enrollment
Secondary	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
Secondary	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
Secondary	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