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Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients

Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02616627
Enrollment
60
Registered
2015-11-30
Start date
2015-09-30
Completion date
2026-02-28
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis, Osteoporosis

Keywords

bone mineral density, chronic dialysis, end-stage renal disease, body composition analysis, sarcopenia

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient characteristics Inclusion Criteria: 1. Age \>20 years and one of the below 2. Chronic hemodialysis 3. Chronic peritoneal dialysis

Exclusion criteria

1\. get pregnant or planning a pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Bone mineral density by DXA,one yearChange of BMD between baseline and one year was measured

Secondary

MeasureTime frameDescription
Blood testsone yearChange of baseline and one year value of various blood tests mentioned in the summary
Sarcopeniabaseline, 6 month and one yearChanges of saropenia percentage at 6 month and one year compared to baseline assessments. 3 measures were used, muscle mass, grip strength, and walking speed

Countries

Taiwan

Contacts

Primary ContactDing-Cheng Chan, MD, PhD
doctord6226@yahoo.com886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026