Renal Osteodystrophy: A Fresh Approach | NCT00859612 | Trialant
CompletedObservationalUpdated May 5, 2017
Renal Osteodystrophy: A Fresh Approach
Renal Osteodystrophy: A Fresh Approach
ClinicalTrials.gov ID
NCT00859612
Lead Sponsor
Hartmut Malluche, MDOTHER
Overall Status
Completed
Study Type
Observational
Enrollment
464Actual
Last Update Posted
May 5, 2017Actual
Start Date
Mar 2009
Primary Completion Date
Feb 2014Actual
Completion Date
Feb 2014Actual
Official Title
Renal Osteodystrophy: A Fresh Approach
Brief Summary
There are two major goals of this project:
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 bone loss.
Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
Renal Osteodystrophy
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.