Clinical trial NCT02616627: Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Official title: Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Osteoporosis
Keywords: bone mineral density
chronic dialysis
end-stage renal disease
body composition analysis
sarcopenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Kidney Disease Requiring Chronic Dialysis

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.

Eligibility 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

Primary outcomes:
measure: Bone mineral density by DXA,
timeFrame: one year
Secondary outcomes:
measure: Blood tests
timeFrame: one year
measure: Sarcopenia
timeFrame: baseline, 6 month and one year
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital, Chutung branch
Study officials:
affiliation: National Taiwan University Hospital, Chutung branch
name: Ding-Cheng Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: