DXA Precision and Accuracy Comparison Study

NCT ID: NCT01530477

Last Updated: 2016-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

Brief Summary

This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat.

Detailed Description

For this study, two specific groups of volunteers will be recruited. In one group, the scan will measure bone density and in the other group the scan will measure fat. The groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. Subjects will have the option to participate in either one or both groups.

Conditions

Osteopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Skeletal

Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)],(total of evaluable 90 subjects).

** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**

Group Type: EXPERIMENTAL

Lunar Prodigy (GEHC)

Intervention Type: DEVICE

Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Lunar iDXA (GEHC)

Intervention Type: DEVICE

Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Discovery A (Hologic

Intervention Type: DEVICE

Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements

Body Composition

Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], and 60 will be measured on all three systems [Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)], (total of evaluable 90 subjects).

** Subjects can enroll in both Skeletal and Body Composition cohorts. Analysis will be performed within each cohort.**

Group Type: EXPERIMENTAL

Lunar Prodigy (GEHC)

Intervention Type: DEVICE

Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Lunar iDXA (GEHC)

Intervention Type: DEVICE

Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Discovery A (Hologic

Intervention Type: DEVICE

Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements

Skeletal & Body Composition

"Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects will be measured on two of three systems \[Lunar Prodigy (GEHC), Lunar iDXA (GEHC) and Discovery A (Hologic)\]Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort.

Group Type: EXPERIMENTAL

Lunar Prodigy (GEHC)

Intervention Type: DEVICE

Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Lunar iDXA (GEHC)

Intervention Type: DEVICE

Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Discovery A (Hologic

Intervention Type: DEVICE

Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements

Interventions

Lunar Prodigy (GEHC)

Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Intervention Type: DEVICE

Lunar iDXA (GEHC)

Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements

Intervention Type: DEVICE

Discovery A (Hologic

Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men and women > 20 years old

2. Willing to provide consent

3. Falls into one of three weight categories, with minimum 30 subjects per category.

• Less than 200 lbs.
• 200 (inclusive) to less than 350 lbs.
• 350 (inclusive) to less than 450 lbs.

4. Participate in only one weight category in either skeletal or body composition cohort, or both.

Exclusion Criteria

1. Inability to remain still for the duration of the DXA scans as judged by study Investigator.

2. Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.

3. Females of childbearing potential* with actual (confirmed by positive urine pregnancy test) or suspected (based on study Investigator evaluation despite a negative urine test) pregnancy.

4. Subject had already given consent to participate in any aspect of this study.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Study site

Locations

Colorado Center for Bone Research

Lakewood, Colorado, United States

Countries

United States

Other Identifiers

101.02-2011-GES-0005

Identifier Type: -

Identifier Source: org_study_id