EOSedge vs DXA Imaging for Bone Density Measurement

Recruiting at 3 trial locations

Overseen By Sr. Manager, Clinical Studies

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alphatec Spine, Inc.

Must not be taking: Contrast agents

Disqualifiers: Pregnancy, BMI ≥ 35, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

214 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of bone imaging, EOSedge and DXA (Dual-Energy X-ray Absorptiometry), in measuring bone density. The goal is to determine if these imaging methods yield similar results, which is crucial for diagnosing conditions like osteoporosis. Healthy volunteers and individuals already scheduled for certain spine or orthopedic x-rays might be suitable candidates. Participants should not have undergone recent contrast dye tests and must be able to stand or lie still during imaging. As an unphased study, this trial allows participants to contribute to important research that could enhance bone health diagnostics.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants who have been administered contrast agents or radionuclides within 7 days prior to imaging.

What prior data suggests that these imaging techniques are safe for bone density measurement?

Research has shown that both EOSedge and DXA imaging are safe for people. The EOSedge system employs low-dose x-ray technology, using less radiation than other methods. Studies indicate a very low risk of developing cancer from EOSedge exams, affecting between 0.02 to 0.25 per million people, making it a safe choice for imaging.

DXA imaging is a common and safe method for measuring bone density. It is widely used in medical settings and maintains a strong safety record.

Overall, both imaging techniques in this trial are considered safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing EOSedge and DXA imaging for measuring bone density because these methods offer different advantages. DXA imaging is the current standard, known for its accuracy and widespread use, but it involves a flat, 2D scan. EOSedge, on the other hand, provides a 3D scan and uses lower radiation doses, which could make it safer for repeated use. This trial aims to find out if EOSedge can match or surpass the accuracy of DXA, potentially offering a more comprehensive and safer option for bone health assessments.

What evidence suggests that EOSedge and DXA imaging are effective for measuring bone density?

This trial will compare EOSedge Imaging with DXA Imaging for bone density measurement. Research on EOSedge Imaging shows that it provides clear, low-dose full-body images, which can help assess bone strength. Studies indicate that EOSedge reduces radiation exposure while still delivering high-quality images, making it safe for regular scans. Although EOSedge effectively evaluates bone health, specific data comparing its accuracy to DXA in predicting fracture risk is lacking. DXA Imaging, however, is a well-known method for measuring bone strength and aiding in the treatment of osteoporosis, a condition where bones become weak and fragile. This trial aims to compare the T-scores (a measure used to assess bone health) between EOSedge and DXA to determine if they align. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are willing to undergo two types of low-dose x-ray exams to compare bone mineral density measurements. Specific eligibility criteria details were not provided.

Inclusion Criteria

Observational Arm: Subjects at clinical sites indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging as part of routine medical care, either completed or scheduled within 60 days of study enrollment

Interventional Arm: Volunteers at non-clinical sites eligible for non-diagnostic imaging as part of a research study

Written informed consent obtained from the potential subject and ability to comply with study requirements

Exclusion Criteria

Subjects who are pregnant or planning pregnancy during the study participation timeframe

Subjects with a condition or abnormality compromising safety or data quality

Subjects with implants, hardware, devices, or foreign material in the measurement area

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo EOSedge and DXA imaging for bone mineral density assessment

0-60 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DXA Imaging
• EOSedge Imaging

Trial Overview The study is testing the agreement in T-scores, which indicate bone mineral density, between EOSedge and traditional DXA imaging technologies.

How Is the Trial Designed?

Group I: Subjects indicated for EOSedge imaging Experimental Treatment 1 Intervention

Subject receiving EOSedge imaging as SOC will also receive an additional DXA scan.

Group II: Healthy Volunteers Experimental Treatment 2 Interventions

Healthy volunteers will undergo EOSedge and DXA imaging

DXA Imaging is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as DXA Imaging for:

• Osteoporosis diagnosis
• Bone mineral density assessment
• Fracture risk evaluation

Approved in United States as DXA Imaging for:

• Osteoporosis diagnosis
• Bone mineral density assessment
• Fracture risk evaluation

Approved in Canada as DXA Imaging for:

• Osteoporosis diagnosis
• Bone mineral density assessment
• Fracture risk evaluation

Approved in Japan as DXA Imaging for:

• Osteoporosis diagnosis
• Bone mineral density assessment
• Fracture risk evaluation

Approved in China as DXA Imaging for:

• Osteoporosis diagnosis
• Bone mineral density assessment
• Fracture risk evaluation

Approved in Switzerland as DXA Imaging for:

• Osteoporosis diagnosis
• Bone mineral density assessment
• Fracture risk evaluation

Who Is Running the Clinical Trial?

Alphatec Spine, Inc.

Lead Sponsor

Trials

9

Recruited

890+

Published Research Related to This Trial

Out of 59 evaluated guidelines on dual energy X-ray absorptiometry (DXA), four met the inclusion criteria, with three of them demonstrating high quality, particularly excelling in the 'Scope and Purpose' domain.

The 'Editorial Independence' domain scored the lowest, indicating a need for improved transparency and independence in future guideline development, while overall interobserver agreement on guideline quality ranged from fair to good.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical appraisal of the quality of adult dual-energy X-ray absorptiometry guidelines in osteoporosis using the AGREE II tool: An EuroAIM initiative. Messina, C., Bignotti, B., Bazzocchi, A., et al.[2022]

A study involving 47 reindeer femora demonstrated that combining bone mineral density (BMD) measurements from dual-energy digital radiography (DEDR) with geometrical parameters can effectively predict the bone's maximal load, which is important for assessing bone strength.

The best predictors of bone fragility included BMD at Ward's triangle along with femoral shaft diameter and femoral neck axis length, showing that both density and geometry are crucial for understanding bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone mineral density and geometry parameters determined in vitro from dual-energy digital radiography images in the assessment of bone maximal load of reindeer femora. Toljamo, PS., Pulkkinen, P., Lammentausta, E., et al.[2016]

Pediatric DXA examinations using the GE Lunar Prodigy scanner deliver effective radiation doses comparable to those from pencil-beam DXA devices, with doses lower than 1 μSv, indicating a low risk of radiation exposure.

The estimated lifetime cancer risks from these examinations are negligible, ranging from 0.02 to 0.25 per million, suggesting that the use of this scanner for assessing bone mineral density in children is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric radiation dose and risk from bone density measurements using a GE Lunar Prodigy scanner. Damilakis, J., Solomou, G., Manios, GE., et al.[2021]

Dual-energy X-ray absorptiometry (DXA) is the standard method for measuring bone mineral density and evaluating osteoporosis, using two X-ray beams to differentiate between soft tissue and bone.

Technical errors and patient-related factors can introduce artifacts in DXA imaging, potentially affecting the accuracy and precision of bone mineral density results, which highlights the importance of proper patient preparation and adherence to procedural guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical and patient-related sources of error and artifacts in bone mineral densitometry using dual-energy X-ray absorptiometry: A pictorial review. Qutbi, M., Soltanshahi, M., Shiravand, Y., et al.[2020]

Dual-energy x-ray absorptiometry (DXA) is the preferred method for measuring bone mineral density, especially in elderly patients and those at risk for osteoporosis, highlighting its importance for early detection of potential fractures.

Understanding the application and interpretation of DXA scans is crucial, as various limitations and conditions can influence the accuracy of the results, which is vital for effective osteoporosis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone densitometry. Interpretation and pitfalls. Agarwal, M., Camacho, P.[2019]

A study evaluating 36 DXA devices from three manufacturers found significant discrepancies in bone mineral density (BMD) measurements, with Lunar devices overestimating BMD values by up to 22%, while Hologic and Osteosys devices showed varying degrees of underestimation.

The results highlight the need for standardization in BMD measurements across different DXA devices, as the accuracy and precision varied significantly, which could impact clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Result of Proficiency Test and Comparison of Accuracy Using a European Spine Phantom among the Three Bone Densitometries. Park, AJ., Choi, JH., Kang, H., et al.[2020]

The dual-energy cone-beam computed tomography (DE-CBCT) technique demonstrated a strong correlation with multislice computed tomography (MSCT) in measuring bone mineral density (BMD), with a Pearson correlation coefficient of 0.982, indicating high reliability.

DE-CBCT provided comparable BMD values to MSCT (1.09±0.07 g/cm3 vs. 1.13±0.08 g/cm3), suggesting it could be a cost-effective alternative for measuring jaw BMD in dental practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical pilot study of jawbone mineral density measured by the newly developed dual-energy cone-beam computed tomography method compared to calibrated multislice computed tomography. Kim, HJ., Kim, JE., Choo, J., et al.[2022]

The new cone beam densitometer, DMS Lexxos, provides low effective radiation doses for patients, measuring 8.4 micro Sv for spine exams and 4.8 micro Sv for femoral neck exams, which is comparable to existing fan-beam densitometers.

Staff exposure is also minimal, with an average dose of 0.23 micro Sv per examination, indicating that this technology is safe for both patients and healthcare providers during bone density assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total dose incurred by patients and staff from BMD measurement using a new 2D digital bone densitometer. Boudousq, V., Kotzki, PO., Dinten, JM., et al.[2018]

The latest DEXA imaging systems deliver a very low effective dose to patients, comparable to just a few microSv during spine and dual femur examinations, indicating a safe level of radiation exposure.

However, these newer systems may require additional shielding due to increased scatter radiation, which could exceed safety limits for staff and the general public, highlighting the need for proper quality assurance and structural protections in facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QA/acceptance testing of DEXA X-ray systems used in bone mineral densitometry. Larkin, A., Sheahan, N., O'Connor, U., et al.[2016]

The study assessed the radiation doses from the Lunar Expert-XL fan beam densitometer, finding that while patient doses are higher than those from traditional pencil beam DXA machines, they remain lower than standard radiographic procedures.

Typical effective doses for various scans using the Lunar Expert-XL range from 56 to 75 muSv, which are acceptable given the benefits of faster scan times and improved image resolution for diagnosing osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of the radiation dose to patients and staff from a Lunar Expert-XL fan beam densitometer. Steel, SA., Baker, AJ., Saunderson, JR.[2019]

Dual-energy X-ray absorptiometry (DXA) is the gold standard for measuring bone mineral density (BMD) and diagnosing osteoporosis, but errors in the scanning process can lead to inaccurate results, potentially causing inappropriate clinical decisions and unnecessary healthcare costs.

Implementing quality control measures, such as certifying DXA technologists and interpreters, is essential to minimize errors and ensure accurate BMD assessments, ultimately improving patient management and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality in dual-energy X-ray absorptiometry scans. Morgan, SL., Prater, GL.[2022]

Dual-energy X-ray absorptiometry (DXA) is a highly accurate and precise method for measuring bone mineral content and density, with a precision of 99% and less than 1% error, making it a reliable tool for assessing bone health.

DXA is a safe imaging technique due to its low radiation exposure, allowing for routine use in both adults and infants, and is particularly useful in nutritional studies for determining body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue composition and bone mineral status: evaluation by dual-energy X-ray absorptiometry. Lukaski, HC.[2022]

Dual energy x-ray absorptiometry (DXA) scans are crucial for assessing bone mineral density (BMD) at the spine and hip, which helps identify individuals at risk for osteoporosis and guides treatment decisions.

DXA scans have several advantages over other bone densitometry methods, including standardized interpretation using the WHO T-score for osteoporosis, proven fracture risk prediction, and effectiveness in monitoring treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. Blake, GM., Fogelman, I.[2022]

A metasynthesis of 13 articles involving 265 participants revealed that many patients have limited understanding of DXA and its importance in osteoporosis prevention, which affects their willingness to undergo screening.

Patients' attitudes towards DXA screening are heavily influenced by their primary care providers, highlighting the need for better education and communication from healthcare professionals to improve patient engagement in osteoporosis prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metasynthesis of Patient Attitudes Toward Bone Densitometry. Seaman, AT., Steffen, M., Doo, T., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06659055

Bone Mineral Density Agreement Study Between EOSedge ... 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 ...

2. withpower.com withpower.com/trial/phase-indicated-for-eosedge-imaging-8-2024-0ef6f

EOSedge vs DXA Imaging for Bone Density Measurement It is effective in predicting fracture risk and guiding treatment decisions. However, there is no specific data provided about EOSedge Imaging in the context ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11252187/

Health technology assessment in musculoskeletal radiology The EOSedge MicroDose protocol significantly reduced the delivered dose while maintaining interpretable image quality and good interrater ...

4. eos-imaging.com eos-imaging.com/us/our-expertise/imaging-solutions/eosedge

EOSedge EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.

5. researchgate.net researchgate.net/publication/235894312_The_EOS_2D3D_X-ray_imaging_system_A_cost-effectiveness_analysis_quantifying_the_health_benefits_from_reduced_radiation_exposure

The EOS 2D/3D X-ray imaging system: A cost-effectiveness ... Results: Standard X-ray is associated with a maximum health loss of 0.001 QALYs, approximately 0.4 of a day in full health, while the loss with ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K202394.pdf

EOS imaging September 16, 2020 Mr. Bernard Ismael Quality ... demonstrates that modified EOSedge is as safe and effective as the cleared EOSedge System. (K192079). Thus, modified EOSedge is substantially ...