DXA Precision and Accuracy Comparison Study (DXA P&A)

• ClinicalTrials.gov Identifier: NCT01530477
• Recruitment Status: Terminated
• First Posted: February 10, 2012
• Results First Posted: September 25, 2014
• Last Update Posted: September 16, 2016
• Sponsor: GE Healthcare
• Information provided by (Responsible Party): GE Healthcare

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Osteopenia
• Interventions: Device: Lunar Prodigy (GEHC); Device: Lunar iDXA (GEHC); Device: Discovery A (Hologic
• Enrollment: 82

Participant Flow

Recruitment Details	A total of 17 subjects consented for the Skeletal Cohort only. A total of 12 subjects consented for the Body Composition Cohort only. A total of 53 subjects consented to participate in both the Skeletal and Body Composition cohorts. Recruitment occurred at the primary site from January to December 2012.
Pre-assignment Details	Subjects were able to consent and participate in one or both cohorts (Outcome Measure Reporting Groups: Skeletal and Body Composition). GE prematurely ended the study with 82 consented individuals but a total of 135 scans were acquired across the cohorts.

Arm/Group Title	Skeletal	Body Composition Only	Skeletal & Body Composition
Arm/Group Description	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, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.	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, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.	"Skeletal & Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. 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.
Period Title: Overall Study
Started	17 [1]	12 [2]	53 [3]
Completed	17 [4]	12 [5]	53 [6]
Not Completed	0	0	0
[1] 17 subjects consented to the Skeletal cohort only.; [2] 12 subjects consented to the Body Composition cohort only.; [3] 53 subjects consented to both the Skeletal and body Composition cohorts.; [4] 17 subjects completed imaging in the Skeletal cohort only.; [5] 12 subjects completed imaging in the Body Composition cohort only.; [6] 53 subjects completed the imaging in both the Skeletal and Body Composition cohorts.

Baseline Characteristics

Arm/Group Title		Skeletal	Body Composition	Skeletal and Body Composition	Total
Arm/Group Description		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, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.	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, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.	"Skeletal and Body Composition" was not a cohort that was actively recruited to, it is a cohort for reporting purposes. 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.	Total of all reporting groups
Overall Number of Baseline Participants		17	12	53	82
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	12 participants	53 participants	82 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	17 100.0%	12 100.0%	53 100.0%	82 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	12 participants	53 participants	82 participants
	Female	8 47.1%	6 50.0%	25 47.2%	39 47.6%
	Male	9 52.9%	6 50.0%	28 52.8%	43 52.4%

Outcome Measures

1. Primary Outcome

Title	Short Term Precision Comparison Across Three DXA Devices
Description	BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the "Skeletal & Body Composition" cohort identified in participant flow and overall study summary will not have an analysis provided.
Time Frame	Less than 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Skeletal	Body Composition Only
Arm/Group Description:	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, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.	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, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
Overall Number of Participants Analyzed	70	65
Measure Type: Number; Unit of Measure: Percentage of variance
iDXA Spine BMD	1.0	NA [1]
Prodigy Spine BMD	1.3	NA [1]
Discovery A Spine BMD	1.2	NA [1]
iDXA Femural neck BMD	1.5	NA [1]
Prodigy Femural neck BMD	1.6	NA [1]
Discovery A Femural neck BMD	2.1	NA [1]
iDXA Total Femur BMD	0.8	NA [1]
Prodigy Total Femur BMD	0.8	NA [1]
Discovery A Total Femur BMD	0.7	NA [1]
iDXA Total Body BMD	NA [2]	0.8
Prodigy Total Body BMD	NA [2]	0.9
Discovery A Total Body BMD	NA [2]	1.9
IDXA Trunk BMD	NA [2]	1
Prodigy Trunk BMD	NA [2]	1.2
Discovery A Trunk BMD	NA [2]	5.8
iDXA Leg BMD	NA [2]	0.8
Prodigy Leg BMD	NA [2]	1.3
Discovery A Leg BMD	NA [2]	1.9

[1]

This "Skeletal" region of interest is not available in the "Body Composition" cohort.

[2]

This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Skeletal	Body Composition
Arm/Group Description	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, and 60 will be measured on all three systems (total of evaluable 90 subjects).	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, and 60 will be measured on all three systems (total of evaluable 90 subjects).
All-Cause Mortality
	Skeletal	Body Composition
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Skeletal	Body Composition
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/70 (0.00%)	0/65 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Skeletal	Body Composition
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/70 (0.00%)	0/65 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Yi Xia
• Organization: GE Healthcare
• Phone: 1 (608) 221-1551 ext 500-3045
• EMail: Yi.Xia@ge.com

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01530477
• Other Study ID Numbers: 101.02-2011-GES-0005
• First Submitted: February 6, 2012
• First Posted: February 10, 2012
• Results First Submitted: June 26, 2013
• Results First Posted: September 25, 2014
• Last Update Posted: September 16, 2016