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Renal Osteodystrophy: A Fresh Approach

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartmut Malluche, MD, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00859612
First received: March 9, 2009
Last updated: May 2, 2017
Last verified: May 2017
  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: Observational Model: Other
Time Perspective: Prospective
Official Title: Renal Osteodystrophy: A Fresh Approach

Resource links provided by NLM:


Further study details as provided by Hartmut Malluche, MD, 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 ]
    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 ]
    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

Enrollment: 464
Study Start Date: March 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Hartmut Malluche, MD
Investigators
Principal Investigator: Hartmut H Malluche, MD University of Kentucky
  More Information

Responsible Party: Hartmut Malluche, MD, Professor and Chief, University of Kentucky
ClinicalTrials.gov Identifier: NCT00859612     History of Changes
Other Study ID Numbers: 1R01DK080770-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: March 9, 2009
Last Updated: May 2, 2017

Additional relevant MeSH terms:
Renal Osteodystrophy
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 28, 2017