EOSedge vs DXA Imaging for Bone Density Measurement

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Alphatec Spine, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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?

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 data supports the idea that EOSedge vs DXA Imaging for Bone Density Measurement is an effective treatment?

The available research shows that DXA Imaging is a well-established method for measuring bone density, especially in people at risk for osteoporosis. It is effective in predicting fracture risk and guiding treatment decisions. However, there is no specific data provided about EOSedge Imaging in the context of bone density measurement, so we cannot compare its effectiveness directly to DXA Imaging based on the information available. ^{1 2 3 4 5}

What safety data exists for DXA and EOSedge imaging for bone density measurement?

DXA imaging, including its variations like fan beam and cone beam systems, generally exposes patients to low levels of radiation, often comparable to a few microSv per examination. Studies indicate that the radiation dose from DXA is lower than standard radiographic procedures and poses negligible cancer risks, especially in pediatric cases. Staff exposure is also low, but protective measures like mobile lead screens may be necessary for newer systems. Quality assurance and certification programs are important to ensure accurate and safe DXA procedures. Specific data on EOSedge imaging is not detailed in the provided research, but it is implied to be a newer technology similar to DXA in terms of safety considerations. ^{6 7 8 9 10}

Is DXA Imaging a promising treatment for measuring bone density?

Yes, DXA Imaging is a promising treatment for measuring bone density. It is the most widely used and trusted method for assessing bone health, especially in people at risk for osteoporosis. DXA provides accurate and precise measurements, helping in early detection and prevention of bone fractures. ^{1 11 12 13 14}

Research Team

Eligibility Criteria

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

Treatment Details

Interventions

• DXA Imaging (Other)
• EOSedge Imaging (Other)

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

Participant Groups

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 Canada, Japan, China, Switzerland for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Bone densitometry. Interpretation and pitfalls. [2019]

2. Korea (South) 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Metasynthesis of Patient Attitudes Toward Bone Densitometry. [2020]

5. Germany 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Total dose incurred by patients and staff from BMD measurement using a new 2D digital bone densitometer. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Pediatric radiation dose and risk from bone density measurements using a GE Lunar Prodigy scanner. [2021]

8. England pubmed.ncbi.nlm.nih.gov

QA/acceptance testing of DEXA X-ray systems used in bone mineral densitometry. [2016]

9. England pubmed.ncbi.nlm.nih.gov

An assessment of the radiation dose to patients and staff from a Lunar Expert-XL fan beam densitometer. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Quality in dual-energy X-ray absorptiometry scans. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Result of Proficiency Test and Comparison of Accuracy Using a European Spine Phantom among the Three Bone Densitometries. [2020]

12. Germany 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. England 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. [2016]