Association of Bone Quality and Quantity With Vascular Ca... | NCT00892853

Studies
Association of Bone Quality and Quantity With Vascular Calcification

NCT00892853

Sponsor

University of Michigan

Status

Withdrawn

Last Update Posted

Jun 12, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Vascular Calcification
Atherosclerosis
Bone Density

Interventions

CT of the bones

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 1, 2009

First Posted Date

May 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2014

Last Update Posted Date

Jun 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bone Density Scanning	Other	To acquire high resolution images of the bones and aid in determining bone density.	Procedure: CT of the bones

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT of the bones	Procedure	A CT scan will be performed on one arm and one leg for the purpose of acquiring images for this research study.	Bone Density Scanning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yebin Jiang, M.D.	University of Michigan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Hospital		Ann Arbor	Michigan	48109	United States

Condition Browse Module

MeSH Terms

ID	Term
D061205	Vascular Calcification
D050197	Atherosclerosis
D002114	Calcinosis
D010024	Osteoporosis

Ancestor Terms

ID	Term
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided