Vascular CalcificationNCT00892853
Association of Bone Quality and Quantity With Vascular Calcification
A study testing CT of the bones in people with Vascular Calcification and Atherosclerosis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Vascular Calcification, Atherosclerosis, Bone Density
- What is being tested?
- CT of the bones
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- 30 years of age or older
- Must already be scheduled to have a CT examination of the arteries of the heart
Who cannot join
- 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
Show all 9Show fewer
- thyroid and adrenal disease
- anorexia nervosa
- secondary osteoporosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Association of Bone Quality and Quantity With Vascular Calcification.
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.
- Conditions
- Vascular Calcification, Atherosclerosis, Bone Density
- Being tested
- CT of the bones
- Keywords
- calcification, osteoporosis
- Medical subject headings
- Vascular Calcification, Atherosclerosis, Calcinosis, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT of the bonesProcedure or surgery
A CT scan will be performed on one arm and one leg for the purpose of acquiring images for this research study.
| Study group | Role | What they receive |
|---|---|---|
| Bone Density Scanning | Other | To acquire high resolution images of the bones and aid in determining bone density. Receives: Procedure: CT of the bones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yebin Jiang, M.D., University of Michigan
- Investigators
- Yebin Jiang, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892853
- Sponsor's protocol ID
- HUM 00022370
- Status last verified
- Jun 2014
- First submitted
- 1 May 2009
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Bone Quality and Quantity With Vascular Calcification.
- ClinicalTrials.gov ID
- NCT00892853
- Acronym / sponsor ID
- HUM 00022370
- Conditions
- Vascular Calcification, Atherosclerosis, Bone Density
- Keywords
- calcification, osteoporosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Density Scanning | Other | Procedure: CT of the bonesTo acquire high resolution images of the bones and aid in determining bone density. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- 30 years of age or older
- Must already be scheduled to have a CT examination of the arteries of the heart
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT of the bonesA CT scan will be performed on one arm and one leg for the purpose of acquiring images for this research study. | Procedure or surgery | Bone Density Scanning |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yebin Jiang, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT of the bones in people with Vascular Calcification and Atherosclerosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2014.