Renal Osteodystrophy: A Fresh Approach

This study is currently recruiting participants.
Verified August 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Hartmut Malluche, MD, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00859612
First received: March 9, 2009
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.

Condition
Renal Osteodystrophy

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

Resource links provided by NLM:


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: Hartmut Malluche, MD, Professor and Chief, 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: August 30, 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 April 14, 2014