Bone CalcificationNCT02165527
Evaluation of Bone Length Measurement
A study testing Lunar iXDA scan in people with Bone Calcification and Osteoporosis, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Calcification, Osteoporosis
- What is being tested?
- Lunar iXDA scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 yrs. of age or older
- Have recent x-rays of lower extremity
- Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.
Who cannot join
- Are unwilling to read and sign the consent
- Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan
- Have severe deformities of your legs or back
- Unable to lay on the scanning table for the scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bone Length Measurement Using Lunar iDXA
The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.
Read the detailed description
The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.
- Conditions
- Bone Calcification, Osteoporosis
- Being tested
- Lunar iXDA scan
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunar iXDA scanProcedure or surgery
Subject will receive a total body scan taken by the Lunar iXDA. This scan will take approximately 8 minutes to complete. Following the scan, the computer of the Lunar iXDA will calculate the bone length.
| Study group | Role | What they receive |
|---|---|---|
| x-ray with iXDA scan | Experimental | Tota body scan taken by the Lunar iXDA. During the scan, subject will be asked to lay on their back. Following the Lunar iDXA scan, the computer of the Luna iXDA will calculate bone length. The calculation of bone length will be compared to a calculation from the subject's conventional x-ray to determine accuracy. Receives: Procedure: Lunar iXDA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg (Femur and Tibia) bone length measurement in centimeters using iDXA
Lunar iXDA computer will calculate the bone length following a total body scan taken by the Lunar iDXA and compare results from conventional x-ray to determine accuracy.
Measured: scan time is 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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
- 20 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, MD, PhD, Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165527
- Sponsor's protocol ID
- HUM29462
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Length Measurement Using Lunar iDXA
- ClinicalTrials.gov ID
- NCT02165527
- Acronym / sponsor ID
- HUM29462
- Conditions
- Bone Calcification, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Jun 2014 (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 Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.
Detailed description
The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| x-ray with iXDA scan | Experimental | Procedure: Lunar iXDA scanTota body scan taken by the Lunar iXDA. During the scan, subject will be asked to lay on their back. Following the Lunar iDXA scan, the computer of the Luna iXDA will calculate bone length. The calculation of bone length will be compared to a calculation from the subject's conventional x-ray to determine accuracy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 yrs. of age or older
- Have recent x-rays of lower extremity
- Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.
Key exclusion criteria (4 listed)
- Are unwilling to read and sign the consent
- Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan
- Have severe deformities of your legs or back
- Unable to lay on the scanning table for the scan
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 |
|---|---|---|
| Lunar iXDA scanSubject will receive a total body scan taken by the Lunar iXDA. This scan will take approximately 8 minutes to complete. Following the scan, the computer of the Lunar iXDA will calculate the bone length. | Procedure or surgery | x-ray with iXDA scan |
Primary outcome
Leg (Femur and Tibia) bone length measurement in centimeters using iDXA
Time frame: scan time is 8 minutes
Lunar iXDA computer will calculate the bone length following a total body scan taken by the Lunar iDXA and compare results from conventional x-ray to determine accuracy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Related trials for Bone Calcification
Not yet recruitingPhase 2
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD
Chronic Kidney Disease Mineral and Bone Disorder, Hypertension
Not yet recruitingObservational study
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
Hemodialysis
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, MD, PhD 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 Lunar iXDA scan in people with Bone Calcification and Osteoporosis, 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 4 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: finished, as of the sponsor's last update on 17 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Leg (Femur and Tibia) bone length measurement in centimeters using iDXA (time frame: scan time is 8 minutes). 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 17 Jun 2014; AzTrials last refreshed its copy on 30 Oct 2026.