Renal Osteodystrophy: A Fresh Approach

This study is currently recruiting participants.

Verified February 2013 by University of Kentucky

Sponsor:

Information provided by (Responsible Party):

University of Kentucky

ClinicalTrials.gov Identifier:

NCT00859612

First received: March 9, 2009

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition
Renal Osteodystrophy

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Renal Osteodystrophy: A Fresh Approach

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary hypophosphatemic rickets

U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
A stepwise logistic model will be used to determine which combination of PTH and bone markers best predicts low bone turnover.

Biospecimen Retention: Samples Without DNA

blood samples and bone biopsy samples

Estimated Enrollment:	417
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients from dialysis clinics

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859612

Locations

United States, Kentucky
University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40536
Contact: Hartmut H Malluche, MD 859-323-5049 ext 221 hhmall@uky.edu
Contact: Marie Faugere, MD 859-323-5049 ext 230 mcfaug0@uky.edu
Principal Investigator: Hartmut H Malluche, MD

Sponsors and Collaborators

University of Kentucky

Investigators

Principal Investigator:

Hartmut H Malluche, MD

University of Kentucky

More Information

No publications provided

Responsible Party:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00859612 History of Changes
Other Study ID Numbers:	1Ro1DK080770-01A1, 1Ro1DK080770-01A1
Study First Received:	March 9, 2009
Last Updated:	February 21, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Parathyroid Diseases
Renal Osteodystrophy
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Rickets
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders

Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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