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Renal Osteodystrophy: A Fresh Approach
This study is enrolling participants by invitation only.
First Received: March 9, 2009   No Changes Posted
Sponsored by: University of Kentucky
Information provided by: University of Kentucky
ClinicalTrials.gov Identifier: NCT00859612
  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

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Renal Osteodystrophy: A Fresh Approach

Further study details as provided by University of Kentucky:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

blood samples and bone biopsy samples


Estimated Enrollment: 417
Study Start Date: March 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (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
Lexington, Kentucky, United States, 40536
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 ( Dr. Hartmut Malluche )
Study ID Numbers: 1Ro1DK080770-01A1, 1Ro1DK080770-01A1
Study First Received: March 9, 2009
Last Updated: March 9, 2009
ClinicalTrials.gov Identifier: NCT00859612     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Vitamin D Deficiency
Parathyroid Diseases
Renal Osteodystrophy
Metabolic Diseases
Avitaminosis
Endocrine System Diseases
Bone Diseases, Metabolic
Bone Diseases
Hyperparathyroidism, Secondary
Malnutrition
Hyperparathyroidism
Musculoskeletal Diseases
Urologic Diseases
Rickets
Neoplasm Metastasis
Nutrition Disorders
Endocrinopathy
Kidney Diseases
Metabolic Disorder
Deficiency Diseases

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

ClinicalTrials.gov processed this record on May 06, 2009