Study Stopped
Early termination due to inability to meet enrollment for \>350lb weight class
DXA Precision and Accuracy Comparison Study
DXA P&A
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2014
CompletedSeptember 16, 2016
August 1, 2016
11 months
February 6, 2012
June 26, 2013
August 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Less than 6 months
Study Arms (3)
Skeletal
EXPERIMENTALRecruitment 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.\*\*
Body Composition
EXPERIMENTALRecruitment 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.\*\*
Skeletal & Body Composition
EXPERIMENTAL"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.
Interventions
Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements
Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements
Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements
Eligibility Criteria
You may qualify if:
- Men and women \> 20 years old
- Willing to provide consent
- Falls into one of three weight categories, with minimum 30 subjects per category.
- Less than 200 lbs.
- (inclusive) to less than 350 lbs.
- (inclusive) to less than 450 lbs.
- Participate in only one weight category in either skeletal or body composition cohort, or both.
You may not qualify if:
- Inability to remain still for the duration of the DXA scans as judged by study Investigator.
- Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
- 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.
- Subject had already given consent to participate in any aspect of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (1)
Colorado Center for Bone Research
Lakewood, Colorado, 80337, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yi Xia
- Organization
- GE Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Miller, MD
Study site
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 10, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 16, 2016
Results First Posted
September 25, 2014
Record last verified: 2016-08