Renal Osteodystrophy: A Fresh Approach

NCT00859612 | Completed

• 1 other identifier: 1R01DK080770-01A1
• Study Type: observational
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

There are two major goals of this project:

1. 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. 2.Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.

Conditions

Renal Osteodystrophy

Outcome Measures

Primary Outcomes (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.

  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.

  4 years

Secondary Outcomes (1)

• Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.

  4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients from dialysis clinics

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hartmut Malluche, MD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and bone biopsy samples

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hartmut H Malluche, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (1)