Renal Osteodystrophy: A Fresh Approach

May 2, 2017 updated by: Hartmut Malluche, MD

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients from dialysis clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartmut Malluche, MD

Investigators

  • Principal Investigator: Hartmut H Malluche, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK080770-01A1 (U.S. NIH Grant/Contract)

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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