RECRUITING

Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge™ Versus Traditional DXA - BMD Agreement Study

Quick Facts

Study Start:2024-09-11

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06659055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Observational Arm: 2. Interventional Arm: 3. Male or female subjects who are at least 20 years of age at the time of imaging acquisition 4. Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study	1. Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA) 2. Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging) 3. Subjects with a BMI ≥ 35 kg/m2 4. 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 5. 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) 6. 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) 7. Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments) 8. Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures 9. 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

Inclusion Criteria

Exclusion Criteria

1. Observational Arm:
2. Interventional Arm:
3. Male or female subjects who are at least 20 years of age at the time of imaging acquisition
4. Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study

1. Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
2. Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
3. Subjects with a BMI ≥ 35 kg/m2
4. 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
5. 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)
6. 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)
7. Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
8. Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
9. 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

Contacts and Locations

Study Contact

Sr. Manager, Clinical Studies

CONTACT

858-603-3139

vshainsky@atecspine.com

Study Locations (Sites)

ATEC Carlsbad

Carlsbad, California, 92008

United States

ATEC Mephis

Memphis, Tennessee, 38118

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Alphatec Spine, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11

Study Completion Date2025-03

Study Record Updates

Study Start Date2024-09-11

Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

Healthy
Indicated for EOSedge Imaging