Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02616627 |
| Other study ID # |
201505154RINB |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
February 2026 |
Study information
| Verified date |
May 2022 |
| Source |
National Taiwan University Hospital |
| Contact |
Ding-Cheng Chan, MD, PhD |
| Phone |
886-2-23123456 |
| Email |
doctord6226[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
