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

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ClinicalTrials.gov Identifier: NCT01530477
Recruitment Status : Terminated (Early termination due to inability to meet enrollment for >350lb weight class)
First Posted : February 10, 2012
Results First Posted : September 25, 2014
Last Update Posted : September 16, 2016
Sponsor:
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
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
Hide 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.
Arm/Group Title Skeletal Body Composition Skeletal and Body Composition Total
Hide 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
Hide 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%
1.Primary Outcome
Title Short Term Precision Comparison Across Three DXA Devices
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Skeletal Body Composition Only
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Skeletal Body Composition
Hide 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   --/--   --/-- 
Hide Serious Adverse Events
Skeletal Body Composition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/65 (0.00%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Yi Xia
Organization: GE Healthcare
Phone: 1 (608) 221-1551 ext 500-3045
EMail: Yi.Xia@ge.com
Layout table for additonal information
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