Renal Osteodystrophy: A Fresh Approach

Renal Osteodystrophy Clinical Trial

Official title:

Renal Osteodystrophy: A Fresh Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859612
• Other study ID #: 1R01DK080770-01A1
• Secondary ID: 1R01DK080770-01A
• Status: Completed
• Phase: N/A
• First received: March 9, 2009
• Last updated: May 2, 2017
• Start date: March 2009
• Est. completion date: February 2014

Study information

• Verified date: May 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Osteodystrophy

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Hartmut Malluche, MD

Country where clinical trial is conducted

United States, 

Outcome

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