Renal Osteodystrophy: A Fresh Approach

Completed

• Conditions: Renal Osteodystrophy

• Registration Number: NCT00859612
• Lead Sponsor: Hartmut Malluche, MD

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 bone loss.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	4 years	Because each method (QCT or DXA) yields a dichotomous response (bone loss: yes or no), the proportion of patients with a bone loss will be compared between the 2 methods by using the McNemar statistic for correlated proportions.

Secondary Outcome Measures

Name	Time	Method
Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.	4 years	A stepwise logistic model will be used to determine which combination of PTH and bone markers best predicts low bone turnover.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States