Trial Outcomes & Findings for DXA Precision and Accuracy Comparison Study (NCT NCT01530477)
NCT ID: NCT01530477
Last Updated: 2016-09-16
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Less than 6 months
Results posted on
2016-09-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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 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.
|
Body Composition Only
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
"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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
53
|
|
Overall Study
COMPLETED
|
17
|
12
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DXA Precision and Accuracy Comparison Study
Baseline characteristics by cohort
| Measure |
Skeletal
n=17 Participants
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.
|
Body Composition
n=12 Participants
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
n=53 Participants
"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
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Less than 6 monthsBMD 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.
Outcome measures
| Measure |
Skeletal
n=70 Participants
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.
|
Body Composition Only
n=65 Participants
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.
|
|---|---|---|
|
Short Term Precision Comparison Across Three DXA Devices
iDXA Spine BMD
|
1.0 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
Prodigy Spine BMD
|
1.3 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
Discovery A Spine BMD
|
1.2 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
iDXA Femural neck BMD
|
1.5 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
Prodigy Femural neck BMD
|
1.6 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
Discovery A Femural neck BMD
|
2.1 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
iDXA Total Femur BMD
|
0.8 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
Prodigy Total Femur BMD
|
0.8 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
Discovery A Total Femur BMD
|
0.7 Percentage of variance
|
NA Percentage of variance
This "Skeletal" region of interest is not available in the "Body Composition" cohort.
|
|
Short Term Precision Comparison Across Three DXA Devices
iDXA Total Body BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
0.8 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
Prodigy Total Body BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
0.9 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
Discovery A Total Body BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
1.9 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
IDXA Trunk BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
1.0 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
Prodigy Trunk BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
1.2 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
Discovery A Trunk BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
5.8 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
iDXA Leg BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
0.8 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
Prodigy Leg BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
1.3 Percentage of variance
|
|
Short Term Precision Comparison Across Three DXA Devices
Discovery A Leg BMD
|
NA Percentage of variance
This "Body Composition" cohort region of interest is not available in the "Skeletal" cohort.
|
1.9 Percentage of variance
|
Adverse Events
Skeletal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Body Composition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60