OsteopeniaDXA P&ANCT01530477
DXA Precision and Accuracy Comparison Study
A study testing Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic in people with Osteopenia, run by GE Healthcare at 1 site in United States.
Trial summary
This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women > 20 years old
- Willing to provide consent
- Falls into one of three weight categories, with minimum 30 subjects per category.
- Less than 200 lbs.
- 200 (inclusive) to less than 350 lbs.
- 350 (inclusive) to less than 450 lbs.
- Participate in only one weight category in either skeletal or body composition cohort, or both.
Who cannot join
- Inability to remain still for the duration of the DXA scans as judged by study Investigator.
- Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
- Females of childbearing potential* with actual (confirmed by positive urine pregnancy test) or suspected (based on study Investigator evaluation despite a negative urine test) pregnancy.
- Subject had already given consent to participate in any aspect of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Center for Bone Research
Lakewood, Colorado, 80337
About this study
This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat.
Read the detailed description
For this study, two specific groups of volunteers will be recruited. In one group, the scan will measure bone density and in the other group the scan will measure fat. The groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. Subjects will have the option to participate in either one or both groups.
- Conditions
- Osteopenia
- Being tested
- Lunar Prodigy (GEHC), Lunar iDXA (GEHC), Discovery A (Hologic
- Keywords
- Bone mineral density, weight, body composition, DEXA, DXA
- Medical subject headings
- Bone Diseases, Metabolic, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lunar Prodigy (GEHC)Device
Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements
Lunar iDXA (GEHC)Device
Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements
Discovery A (HologicDevice
Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements
| Study group | Role | What they receive |
|---|---|---|
| Skeletal | Experimental | Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)],(total of evaluable 90 subjects).
Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort. Receives: Device: Lunar Prodigy (GEHC); Device: Lunar iDXA (GEHC); Device: Discovery A (Hologic |
| Body Composition | Experimental | Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], (total of evaluable 90 subjects).
Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort. Receives: Device: Lunar Prodigy (GEHC); Device: Lunar iDXA (GEHC); Device: Discovery A (Hologic |
| Skeletal & Body Composition | Experimental | "Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)]Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort. Receives: Device: Lunar Prodigy (GEHC); Device: Lunar iDXA (GEHC); Device: Discovery A (Hologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Term Precision Comparison Across Three DXA Devices
BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the "Skeletal \& Body Composition" cohort identified in participant flow and overall study summary will not have an analysis provided.
Measured: Less than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Early termination due to inability to meet enrollment for \>350lb weight class
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Miller, MD, Principal investigator, Study site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530477
- Sponsor's protocol ID
- 101.02-2011-GES-0005
- Acronym
- DXA P&A
- Status last verified
- Aug 2016
- First submitted
- 6 Feb 2012
- Last updated
- 16 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DXA Precision and Accuracy Comparison Study
- ClinicalTrials.gov ID
- NCT01530477
- Acronym / sponsor ID
- DXA P&A / 101.02-2011-GES-0005
- Conditions
- Osteopenia
- Keywords
- Bone mineral density, weight, body composition, DEXA, DXA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to inability to meet enrollment for \>350lb weight class
- Enrolment
- 82 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat.
Detailed description
For this study, two specific groups of volunteers will be recruited. In one group, the scan will measure bone density and in the other group the scan will measure fat. The groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. Subjects will have the option to participate in either one or both groups.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skeletal | Experimental | Device: Lunar Prodigy (GEHC), Device: Lunar iDXA (GEHC), Device: Discovery A (HologicRecruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)],(total of evaluable 90 subjects). Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort. |
| Body Composition | Experimental | Device: Lunar Prodigy (GEHC), Device: Lunar iDXA (GEHC), Device: Discovery A (HologicRecruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], (total of evaluable 90 subjects). Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort. |
| Skeletal & Body Composition | Experimental | Device: Lunar Prodigy (GEHC), Device: Lunar iDXA (GEHC), Device: Discovery A (Hologic"Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)]Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women > 20 years old
- Willing to provide consent
- Falls into one of three weight categories, with minimum 30 subjects per category.
- Participate in only one weight category in either skeletal or body composition cohort, or both.
Key exclusion criteria (4 listed)
- Inability to remain still for the duration of the DXA scans as judged by study Investigator.
- Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
- Females of childbearing potential* with actual (confirmed by positive urine pregnancy test) or suspected (based on study Investigator evaluation despite a negative urine test) pregnancy.
- Subject had already given consent to participate in any aspect of this study.
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 Prodigy (GEHC)Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements | Device | Body Composition, Skeletal, Skeletal & Body Composition |
| Lunar iDXA (GEHC)Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements | Device | Body Composition, Skeletal, Skeletal & Body Composition |
| Discovery A (HologicDiscovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements | Device | Body Composition, Skeletal, Skeletal & Body Composition |
Primary outcome
Short Term Precision Comparison Across Three DXA Devices
Time frame: Less than 6 months
BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the "Skeletal \& Body Composition" cohort identified in participant flow and overall study summary will not have an analysis provided.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Miller, MD principal investigator
Study site
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 Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic in people with Osteopenia, run by GE Healthcare 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 7 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: stopped early, as of the sponsor's last update on 16 Sep 2016. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Short Term Precision Comparison Across Three DXA Devices (time frame: Less than 6 months). 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 16 Sep 2016.