HealthyNCT06659055
Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
A study testing DXA Imaging and EOSedge imaging in people with Healthy and Indicated for EOSedge Imaging, run by Alphatec Spine, Inc. at 4 sites in United States.
Trial summary
The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low-dose x-ray exams, EOSedge and conventional DXA. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Indicated for EOSedge Imaging
- What is being tested?
- DXA Imaging and EOSedge imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Observational Arm:
- o Subjects at clinical sites, indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/or other orthopaedic conditions) as part of their routine medical care. Participants may already have completed their routine imagining, or may be scheduled to undergo it within 60 days of study enrollment.
- Interventional Arm:
- o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study.
- Male or female subjects who are at least 20 years of age at the time of imaging acquisition
- Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study
Who cannot join
- Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
- Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
- Subjects with a BMI ≥ 35 kg/m2
- Subjects known to have severe degenerative changes or fracture deformity in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable), as defined by the Investigator's determination of the likelihood of reasonably assessing bone mineral density of those areas
- Subjects known to have implants, hardware, devices, or other foreign material in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable)
- Subjects unable to attain correct position and/or remain motionless for the measurement (e.g., subjects unable to stand unassisted in the EOS unit, or to lie appropriately in the DXA scanner)
Show all 9Show fewer
- Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
- Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
- Subjects with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 2 recruiting
- Active, not recruiting
ATEC Carlsbad
Carlsbad, California, 92008
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Lockey
- Active, not recruiting
ATEC Mephis
Memphis, Tennessee, 38118
- Recruiting
Honor Health
Phoenix, Arizona, 85027
Lee
About this study
Official title: Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge™ Versus Traditional DXA - BMD Agreement Study
The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low-dose x-ray exams, EOSedge and conventional DXA. The main question it aims to answer is:
Is there agreement between the calculated T-scores between the 2 different types of x-ray exams?
Read the detailed description
This is a multi-center, prospective, controlled, cross-sectional agreement study of subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging OR volunteers undergoing non-diagnostic imaging.
From the potential pool of EOSedge examinees, screening data will be reviewed to determine further eligibility. Subjects who sign an informed consent form and meet all inclusion criteria and none of the exclusion criteria will be asked to participate in the study.
Subjects who consent to participate will be enrolled from the time of consent through completion of evaluable image acquisition which will include both EOSedge and DXA scans.
EOSedge exams will be performed as is typical for the evaluation of spinal and/or other orthopaedic conditions, and the output will be collected for post-hoc computation of BMD.
DXA exams will be study-prescribed (or standard of care if consistent with this protocol) and ideally performed on the same day as EOSedge exams (but may be scheduled as much as 60 days apart).
In addition to the radiographic imaging from which spinal/postural alignment parameters may be obtained, some demographic and diagnostic details about the subject will be captured via study-specific case report forms (CRFs). Subjects will also complete a questionnaire that every subject fills out prior to having a DXA scan according to ISCD guidance.
- Conditions
- Healthy, Indicated for EOSedge Imaging
- Being tested
- DXA Imaging, EOSedge imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA ImagingRadiation
DXA imaging: lumbar spine, bi-lateral femoral necks
EOSedge imagingRadiation
Full body or full spine image
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Healthy volunteers will undergo EOSedge and DXA imaging Receives: Radiation: DXA Imaging; Radiation: EOSedge imaging |
| Subjects indicated for EOSedge imaging | Other | Subject receiving EOSedge imaging as SOC will also receive an additional DXA scan. Receives: Radiation: DXA Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
AP Spine T-score Agreement
Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass on four lumbar vertebrae (L1-L4) in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the spine (AP L1-L4) exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems.
Measured: between 0-60 days
Secondary outcomes (1)
Hip T-score Agreement
Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass at the femoral neck in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the hip exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems.
Measured: between 0-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start11 Sep 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alphatec Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659055
- Sponsor's protocol ID
- ATEC.EOS-2402
- Status last verified
- Feb 2025
- First submitted
- 22 Oct 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge™ Versus Traditional DXA - BMD Agreement Study
- ClinicalTrials.gov ID
- NCT06659055
- Acronym / sponsor ID
- ATEC.EOS-2402
- Conditions
- Healthy, Indicated for EOSedge Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- 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 research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low-dose x-ray exams, EOSedge and conventional DXA. The main question it aims to answer is:
Is there agreement between the calculated T-scores between the 2 different types of x-ray exams?
Detailed description
This is a multi-center, prospective, controlled, cross-sectional agreement study of subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging OR volunteers undergoing non-diagnostic imaging.
From the potential pool of EOSedge examinees, screening data will be reviewed to determine further eligibility. Subjects who sign an informed consent form and meet all inclusion criteria and none of the exclusion criteria will be asked to participate in the study.
Subjects who consent to participate will be enrolled from the time of consent through completion of evaluable image acquisition which will include both EOSedge and DXA scans.
EOSedge exams will be performed as is typical for the evaluation of spinal and/or other orthopaedic conditions, and the output will be collected for post-hoc computation of BMD.
DXA exams will be study-prescribed (or standard of care if consistent with this protocol) and ideally performed on the same day as EOSedge exams (but may be scheduled as much as 60 days apart).
In addition to the radiographic imaging from which spinal/postural alignment parameters may be obtained, some demographic and diagnostic details about the subject will be captured via study-specific case report forms (CRFs). Subjects will also complete a questionnaire that every subject fills out prior to having a DXA scan according to ISCD guidance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Radiation: DXA Imaging, Radiation: EOSedge imagingHealthy volunteers will undergo EOSedge and DXA imaging |
| Subjects indicated for EOSedge imaging | Other | Radiation: DXA ImagingSubject receiving EOSedge imaging as SOC will also receive an additional DXA scan. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Observational Arm:
- o Subjects at clinical sites, indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/or other orthopaedic conditions) as part of their routine medical care. Participants may already have completed their routine imagining, or may be scheduled to undergo it within 60 days of study enrollment.
- Interventional Arm:
- o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study.
- Male or female subjects who are at least 20 years of age at the time of imaging acquisition
Key exclusion criteria (9 listed)
- Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
- Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
- Subjects with a BMI ≥ 35 kg/m2
- Subjects known to have severe degenerative changes or fracture deformity in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable), as defined by the Investigator's determination of the likelihood of reasonably assessing bone mineral density of those areas
- Subjects known to have implants, hardware, devices, or other foreign material in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable)
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 |
|---|---|---|
| DXA ImagingDXA imaging: lumbar spine, bi-lateral femoral necks | Radiation | Healthy Volunteers, Subjects indicated for EOSedge imaging |
| EOSedge imagingFull body or full spine image | Radiation | Healthy Volunteers |
Primary outcome
AP Spine T-score Agreement
Time frame: between 0-60 days
Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass on four lumbar vertebrae (L1-L4) in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the spine (AP L1-L4) exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems.
1 secondary outcome
Hip T-score Agreement
Time frame: between 0-60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DXA Imaging and EOSedge imaging in people with Healthy and Indicated for EOSedge Imaging, run by Alphatec Spine, Inc. at 4 sites 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 6 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sr. Manager, Clinical Studies (858-603-3139, vshainsky@atecspine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AP Spine T-score Agreement (time frame: between 0-60 days). 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 14 Feb 2025.