NCT00892853

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 12, 2014

Status Verified

June 1, 2014

Enrollment Period

3.9 years

First QC Date

May 1, 2009

Last Update Submit

June 11, 2014

Conditions

Vascular CalcificationAtherosclerosisBone Density

Keywords

calcificationosteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Bone Density Scanning

OTHER

To acquire high resolution images of the bones and aid in determining bone density.

Procedure: CT of the bones

Interventions

CT of the bonesPROCEDURE

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

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • years of age or older
  • Must already be scheduled to have a CT examination of the arteries of the heart

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Vascular CalcificationAtherosclerosisCalcinosisOsteoporosis

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Study Officials

  • Yebin Jiang, M.D.

    University of Michigan Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 5, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 12, 2014

Record last verified: 2014-06

Locations

US(1)