Status:
COMPLETED
Renal Osteodystrophy: A Fresh Approach
Lead Sponsor:
Hartmut Malluche, MD
Conditions:
Renal Osteodystrophy
Eligibility:
All Genders
18+ years
Brief Summary
There are two major goals of this project: 1. Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bo...
Eligibility Criteria
Inclusion
- Aged 18 years or older;
- Chronic maintenance dialysis of at least 3 months' duration;
- Mental competence;
- Willingness to participate in the study;
- Calcidiol levels within normal range.
Exclusion
- Pregnancy;
- Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
- Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
- Chronic alcoholism and/or drug addiction;
- Participation in a study of an investigational drug during the past 90 days;
- Allergy to tetracycline.
- Planning to move out of the area within 2 years of the study;
- On active transplant list;
- Treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics).
- Calcidiol level below the normal range. The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT00859612
Start Date
March 1 2009
End Date
February 1 2014
Last Update
May 5 2017
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536