Renal Osteodystrophy: A Fresh Approach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

464 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-02-28

Brief Summary

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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 bone loss.
2. Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.

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Detailed Description

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Conditions

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Renal Osteodystrophy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No