- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485706
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
Renal patients have an increased risk for cardiovascular complications. There is also increased vascular calcification and bone metabolism is similarly abnormal in patients with chronic kidney disease.
In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering capacity in dialysis patients can be a mechanism for vascular calcifications.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study hypothesis.
Patient with a higher ∆ Calcium (Calcium post - Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller ∆ Calcium.
This may result in higher extraosseous calcification and higher pulse wave velocity
∆ PTH/∆ Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid "health"
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
LEuven, Belgium, 3000
- UZ Gasthuisberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- maintenance hemodialysis patients
Exclusion Criteria:
- dialysis <3 months
- aortobifemoral graft
- calcium level predialysis >10.5 mg/dl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
correlation between calcium increase and pulse wave velocity
|
correlation between calcium increase and pulse wave velocity
|
correlation between calcium change and pth change
|
correlation between calcium change and pth change
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
correlation between calcium increase and vascular calcifications
|
correlation between calcium increase and vascular calcifications
|
correlation between calcium change and bone markers
|
correlation between calcium change and bone markers
|
Collaborators and Investigators
Investigators
- Principal Investigator: kathleen Claes, MD, UZ Gasthuisberg
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML4181
- S50455
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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