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NCT number NCT02616627
Study type Observational
Source National Taiwan University Hospital
Contact Ding-Cheng Chan, MD, PhD
Phone 886-2-23123456
Email doctord6226@yahoo.com
Status Recruiting
Phase N/A
Start date September 2015
Completion date February 2017

Clinical Trial Summary

Aims:

1. To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients.

2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.

Method:

In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes. Patients will receive DXA (including BMD and body composition) tests and blood work at baseline and one-year. Muscle power and physical performance will be measured at baseline, 6 months and one-year.


Clinical Trial Description

Background:

Several large-scale studies enrolling CKD patients discovered that low BMD is still an important risk factor for developing fragility fractures, while chronic dialysis patients are reported to have 4 to5 fold higher risk of fracture compared to general population. However, the relationship between bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and fracture and other adverse events in patients with CKD patients is still unclear. In addition, declining of renal function could affect the normal physiological regulating of blood levels of calcium, phosphate, fibroblast growth factor 23 (FGF23), parathyroid hormone (PTH), and vitamin D, which could influence the bone mineral density of chronic dialysis patients. Recently, it is well known that serum FGF23 is already elevated at the early stage of CKD patients and independently related to CKD. However, there are a limited number of reports indicate that the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients.

Aims:

1. To determine whether BMD by DXA was associated with fractures and other adverse events in dialysis patients.

2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.

Method:

In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes.

Patient characteristics

Inclusion Criteria:

1. Age >20 years and one of the below

2. Chronic hemodialysis

3. Chronic peritoneal dialysis

Exclusion Criteria:

get pregnant or planning a pregnancy

Anticipated results:

1. The investigators expect that results and findings discovered from this study could show the effects of interactions of FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients, which should be an important step on improving clinical decision for osteoporosis and fracture risk in renal dialysis patients.

2. Publishing results in an academic journal.


Study Design

Observational Model: Case-Only


Related Conditions & MeSH terms


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