Back to resultsAssociation of Bone Quality and Quantity With Vascular Calcification
Primary Purpose
Vascular Calcification, Atherosclerosis, Bone Density
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT of the bones
Sponsored by
About this trial
This is an interventional diagnostic trial for Vascular Calcification focused on measuring calcification, osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- 30 years of age or older
- Must already be scheduled to have a CT examination of the arteries of the heart
Exclusion Criteria:
- Diagnosed with bone cancer
- Previous diagnosis of cancer that's spread to the bone
- History of cancer that involves bone marrow
- Any bone disease other than osteoporosis
Any disease which leads to serious osteoporosis or vascular calcification such as:
- kidney disease
- thyroid and adrenal disease
- anorexia nervosa
- secondary osteoporosis
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bone Density Scanning
Arm Description
To acquire high resolution images of the bones and aid in determining bone density.
Outcomes
Primary Outcome Measures
To determine if there is a connection between heart disease and bone disease through correlation of bone density with the calcium deposited in the coronary arteries.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00892853
Brief Title
Association of Bone Quality and Quantity With Vascular Calcification
Official Title
Association of Bone Quality and Quantity With Vascular Calcification.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if there is a link between calcium build up in the veins or arteries (including the veins/arteries of the heart) and deterioration of the bone. This will help understand if there is a connection between heart disease and bone disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Calcification, Atherosclerosis, Bone Density
Keywords
calcification, osteoporosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone Density Scanning
Arm Type
Other
Arm Description
To acquire high resolution images of the bones and aid in determining bone density.
Intervention Type
Procedure
Intervention Name(s)
CT of the bones
Intervention Description
A CT scan will be performed on one arm and one leg for the purpose of acquiring images for this research study.
Primary Outcome Measure Information:
Title
To determine if there is a connection between heart disease and bone disease through correlation of bone density with the calcium deposited in the coronary arteries.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female
30 years of age or older
Must already be scheduled to have a CT examination of the arteries of the heart
Exclusion Criteria:
Diagnosed with bone cancer
Previous diagnosis of cancer that's spread to the bone
History of cancer that involves bone marrow
Any bone disease other than osteoporosis
Any disease which leads to serious osteoporosis or vascular calcification such as:
kidney disease
thyroid and adrenal disease
anorexia nervosa
secondary osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yebin Jiang, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Association of Bone Quality and Quantity With Vascular Calcification
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