Osteopenia
Conditions
Keywords
Bone mineral density, weight, body composition, DEXA, DXA
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.
Interventions
DEVICELunar Prodigy (GEHC)
Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements
DEVICELunar iDXA (GEHC)
Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements
DEVICEDiscovery A (Hologic
Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Term Precision Comparison Across Three DXA Devices | Less than 6 months | 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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, 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. | 12 |
| Skeletal and Body Composition 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. | 53 |
| Total | 82 |
Baseline characteristics
| Characteristic | Total | Skeletal | Body Composition | Skeletal and Body Composition |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants | 17 Participants | 12 Participants | 53 Participants |
| Sex: Female, Male Female | 39 Participants | 8 Participants | 6 Participants | 25 Participants |
| Sex: Female, Male Male | 43 Participants | 9 Participants | 6 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 65 |
| serious Total, serious adverse events | 0 / 70 | 0 / 65 |
Outcome results
Primary
Short Term Precision Comparison Across Three DXA Devices
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Discovery A Femural neck BMD | 2.1 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Prodigy Total Body BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | iDXA Femural neck BMD | 1.5 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Discovery A Total Body BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | iDXA Total Femur BMD | 0.8 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | IDXA Trunk BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Discovery A Spine BMD | 1.2 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Prodigy Trunk BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Prodigy Total Femur BMD | 0.8 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Discovery A Trunk BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Prodigy Femural neck BMD | 1.6 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | iDXA Leg BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Discovery A Total Femur BMD | 0.7 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Prodigy Leg BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Prodigy Spine BMD | 1.3 Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | Discovery A Leg BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | iDXA Total Body BMD | NA Percentage of variance |
| Skeletal | Short Term Precision Comparison Across Three DXA Devices | iDXA Spine BMD | 1.0 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | iDXA Total Body BMD | 0.8 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Prodigy Spine BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Discovery A Spine BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | iDXA Femural neck BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Prodigy Femural neck BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Discovery A Femural neck BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | iDXA Total Femur BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Prodigy Total Femur BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Discovery A Total Femur BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | iDXA Spine BMD | NA Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Prodigy Total Body BMD | 0.9 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Discovery A Total Body BMD | 1.9 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | IDXA Trunk BMD | 1.0 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Prodigy Trunk BMD | 1.2 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Discovery A Trunk BMD | 5.8 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | iDXA Leg BMD | 0.8 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Prodigy Leg BMD | 1.3 Percentage of variance |
| Body Composition Only | Short Term Precision Comparison Across Three DXA Devices | Discovery A Leg BMD | 1.9 Percentage of variance |