Renal Osteodystrophy: A Fresh Approach

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014