Clinical trial NCT02147782: Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency
Official title: Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Renal Insufficiency
Renal Osteodystrophy
Keywords: chronic renal insufficient, renal osteodystrophy, bone mineral density, bone turnover, kidney function
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Anhui Provincial Hospital
name: Huadong Hospital
name: Longhua Hospital
First posted: 2014-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: bone metabolism (bone mineral density and serum bone turnover biomarkers)
timeFrame: 1 day after enrollment
Secondary outcomes:
measure: Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate）
timeFrame: 1 day after enrollment
measure: Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD)
timeFrame: 1 day after enrollment
measure: MicroRNA array
timeFrame: 1 day after enrollment
Other outcomes:
measure: Baseline information （height, weight, sex）
timeFrame: 1 day after enrollment
Locations:
city: Hefei
country: China
facility: Anhui Province Hospital of TCM
state: Anhui
city: Nanjing
country: China
facility: Jiangsu Province Hospital of TCM
state: Jiangsu
city: Shanghai
country: China
facility: Longhua hospital affiliated to Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Shanhgai University of TCM
name: Yongjun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: