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.12345
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.678910
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.111121314
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
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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
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Treatment Details
Interventions
- DXA Imaging (Other)
- EOSedge Imaging (Other)
Trial OverviewThe study is testing the agreement in T-scores, which indicate bone mineral density, between EOSedge and traditional DXA imaging technologies.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Subjects indicated for EOSedge imagingExperimental Treatment1 Intervention
Subject receiving EOSedge imaging as SOC will also receive an additional DXA scan.
Group II: Healthy VolunteersExperimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Honor HealthPhoenix, AZ
ATEC MephisMemphis, TN
University of VirginiaCharlottesville, VA
ATEC CarlsbadCarlsbad, CA
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Who Is Running the Clinical Trial?
Alphatec Spine, Inc.Lead Sponsor
References
Bone densitometry. Interpretation and pitfalls. [2019]Dual-energy x-ray absorptiometry (DXA) is the method of choice to measure bone mineral density in elderly patients and others at risk for osteoporosis. Early detection is important because fractures represent an enormous health burden. In this article, the authors discuss the application and interpretation of DXA scans as well as limitations and conditions that can affect results.
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]This clinical pilot study was performed to determine the effectiveness of dual-energy cone-beam computed tomography (DE-CBCT) in measuring bone mineral density (BMD).
The role of DXA bone density scans in the diagnosis and treatment of osteoporosis. [2022]Dual energy x ray absorptiometry (DXA) scans to measure bone mineral density (BMD) at the spine and hip have an important role in the evaluation of individuals at risk of osteoporosis, and in helping clinicians advise patients about the appropriate use of antifracture treatment. Compared with alternative bone densitometry techniques, hip and spine DXA examinations have a number of advantages that include a consensus that BMD results can be interpreted using the World Health Organization T-score definition of osteoporosis, a proven ability to predict fracture risk, proven effectiveness at targeting antifracture therapies, and the ability to monitor response to treatment. This review discusses the evidence for these and other clinical aspects of DXA scanning, including its role in the new WHO algorithm for treating patients on the basis of their individual fracture risk.
Metasynthesis of Patient Attitudes Toward Bone Densitometry. [2020]Bone densitometry (e.g., dual-energy X-ray absorptiometry or "DXA") is strongly associated with osteoporosis treatment; however, rates of DXA are low. While studies have demonstrated a continued need for primary care provider education on the role of DXA in preventive care, little is known about the role of patient attitudes toward DXA. This review's purpose is to synthesize the evidence about the effects of patient perceptions and experiences of DXA on osteoporosis prevention.
Technical and patient-related sources of error and artifacts in bone mineral densitometry using dual-energy X-ray absorptiometry: A pictorial review. [2020]Dual-energy X-ray absorptiometry is currently the standard and validated tool for measurement of bone mineral density and for the evaluation of osteoporosis. Current densitometry scanners based on dual-energy X-ray absorptiometry method produce two X-ray beams with different energies to differentiate the overlapped soft tissue and bony structures, by creating two different attenuation profiles. Procedural guidelines are available to technicians and physicians to guarantee the best practice, including consistent positioning during scanning and standard reporting. However, similar to other imaging modalities, dual-energy X-ray absorptiometry may be influenced by technical errors, and thus, imaging artifacts may arise and accuracy and precision of the results may be influenced. This issue may, in turn, affect the final result and interpretation. Hence, the article is arranged with the intention of presenting some less common and rare technical and patient-related sources of error and resultant artifacts, from poor patient preparation to acquisition and data processing. Where appropriate, the corresponding tables of densitometric results (bone mineral density) and statistical parameters (T- and Z-scores) are provided.
Total dose incurred by patients and staff from BMD measurement using a new 2D digital bone densitometer. [2018]Dual energy X-ray absorptiometry (DXA) is a widely used and precise technique for non-invasive assessment of bone mineral density. The DXA systems have evolved from pencil X-ray beam (single detector) to fan beam (linear array detector) and recently cone beam densitometers (bi-dimensional detector), allowing for an examination to occur without any scanning and with a short acquisition time. The purpose of this study was to evaluate patient and staff dose from a new cone beam densitometer, the DMS Lexxos. Measurements were performed on a DMS Lexxos bone densitometer prototype. An anthropomorphic phantom and thermoluminescent dosimeters were used to evaluate the effective dose. Ionization chambers and electronic personal dosimeters were used to evaluate the staff dose. The effective dose is 8.4 micro Sv for an anteroposterior spine examination and 4.8 micro Sv for a femoral neck in standard mode. The averaged scattered dose rate (ambient dose equivalent) at 1 m from the beam is evaluated at 226 micro Sv/h. Assuming six patients per hour with two views per patient, the time averaged dose rate is evaluated at 2.9 micro Sv/h. By the personal dosimeter, the staff dose (Hp 10) at 1 m from the beam is evaluated at 0.23 micro Sv per examination. For one examination, patient and staff dose from this new technology remains low: in the same range as the fan-beam densitometer.
Pediatric radiation dose and risk from bone density measurements using a GE Lunar Prodigy scanner. [2021]Effective radiation doses associated with bone mineral density examinations performed on children using a GE Lunar Prodigy fan-beam dual-energy X-ray absorptiometry (DXA) scanner were found to be comparable to doses from pencil-beam DXA devices, i.e., lower than 1 μSv. Cancer risks associated with acquisitions obtained in this study are negligible.
QA/acceptance testing of DEXA X-ray systems used in bone mineral densitometry. [2016]New developments in dual energy X-ray absorptiometry (DEXA) imaging technology [fan beam and cone beam (CB)] result in higher exposure levels, shorter scan times, increased patient throughput and increased shielding requirements. This study presents the results of a European survey detailing the number and location of DEXA systems in SENTINEL partner states and the QA (quality assurance) currently performed by physicists and operators in these centres. The results of a DEXA equipment survey based on an in-house developed QA protocol are presented. Measurements show that the total effective dose to the patient from a spine and dual femur DEXA examination on the latest generation DEXA systems is comparable with a few microSv at most. Scatter measurements showed that the use of a mobile lead screen for staff protection was necessary for fan and CB systems. Scattered dose from newer generation systems may also exceed the exposure limits for the general public so structural shielding may also be required. Considerable variation in the magnitude and annual repeatability of half value layer was noted between different models of DEXA scanners. A comparative study of BMD (bone mineral density) accuracy using the European Spine Phantom highlighted a deviation of up to 7% in BMD values between scanners of different manufacturers.
An assessment of the radiation dose to patients and staff from a Lunar Expert-XL fan beam densitometer. [2019]Dual-energy x-ray absorptiometry (DXA) is a widely used technique for measuring bone mineral density for the identification and management of osteoporotic subjects. The original DXA pencil beam systems expose patients to an effective dose of ionizing radiation of around 2 muSv and require no additional protective shielding for staff. The new fan beam densitometers incorporate solid state detectors and have a higher photon flux, enabling faster acquisition times and giving improved resolution. However, this may be at the expense of higher radiation dose. This study was conducted to assess the radiation dose to patients and staff from the standard scan modes using a Lunar Expert-XL fan beam densitometer. This is, we believe, the first dose assessment of the Expert-XL. The results indicate that the scatter dose at 1 m from the scan table, assuming four AP spine and femoral neck examinations per hour, is about 4 muSv h-1. This is well below the limit of 7.5 muSv h-1 set by the UK's Ionising Radiation Regulations for defining a Controlled Area but above the lesser limit of 2.5 muSv h-1 for a Supervised Area. Typical effective doses to patients are 59 muSv for an AP lumbar spine scan, up to 56 muSv for AP femoral neck, 71 muSv for lateral spine morphometry and 75 muSv for whole body. Although exceeding those of pencil beam DXA machines, these doses are less than for standard radiographic procedures, particularly of the lumbar spine. Where reduced scan time, improved image resolution or morphometric analysis of the spine are required, the patient doses from the Lunar Expert-XL are not prohibitive.
Quality in dual-energy X-ray absorptiometry scans. [2022]Dual-energy X-ray absorptiometry (DXA) is the gold standard for measuring bone mineral density (BMD), making the diagnosis of osteoporosis, and for monitoring changes in BMD over time. DXA data are also used in the determination of fracture risk. Procedural steps in DXA scanning can be broken down into scan acquisition, analysis, interpretation, and reporting. Careful attention to quality control pertaining to these procedural steps should theoretically be beneficial in patient management. Inattention to procedural steps and errors that may occur at each step has the possibility of providing information that would inform inappropriate clinical decisions, generating unnecessary healthcare expenses and ultimately causing avoidable harm to patients. This article reviews errors in DXA scanning that affect trueness and precision related to the machine, the patient, and the technologist and reviews articles which document problems with DXA quality in clinical and research settings. An understanding of DXA errors is critical for DXA quality; programs such as certification of DXA technologists and interpreters help in assuring quality bone densitometry. As DXA errors are common, pay for performance requiring DXA technologists and interpreters to be certified and follow quality indicators is indicated.
Result of Proficiency Test and Comparison of Accuracy Using a European Spine Phantom among the Three Bone Densitometries. [2020]Although dual energy X-ray absorptiometry (DXA) is known to standard equipment for bone mineral density (BMD) measurements. Different results of BMD measurement using a number of different types of devices are difficult to use clinical practice. The purpose of this study was to evaluate discrepancy and standardizations of DXA devices from three manufactures using a European Spine Phantom (ESP).
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]Dual energy X-ray absorptiometry (DXA) is the most widely used technique to measure bone mineral density (BMD). Appropriate and accurate use of DXA is of great importance, and several guidelines have been developed in the last years. Our aim was to evaluate the quality of published guidelines on DXA for adults.
Soft tissue composition and bone mineral status: evaluation by dual-energy X-ray absorptiometry. [2022]Dual-energy X-ray absorptiometry (DXA) is a new method for assessing whole-body and regional bone, fat and fat-free mineral-free soft tissue masses. X-rays at two discrete energy levels are collimated and directed into the body. The attenuation of the X-rays by the various chemical components in the body permits determination of important compositional variables. The precision and accuracy of the DXA measurements of bone mineral content and density are 99% and
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]Dual-energy digital radiography (DEDR) has been shown to be a potential method to determine bone mineral density (BMD) and predict maximal load with similar accuracy as standard bone densitometry using DXA (dual-energy X-ray absorptiometry). In addition to bone density, bone geometry has also been shown to have effect on bone fragility and fracture risk.