Bone and BonesNCT03621306
DXA Study of Precision and Reliability
An observational study of Bone and Bones and Body Composition, run by Penn State University at 1 site in United States.
Trial summary
The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner. Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone and Bones, Body Composition
- What is being tested?
- DXA and pQCT precision testing
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2008to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers will include men and women of all ages. Women must not be pregnant.
Who may be able to join
- Healthy adults of two age groups, 1) aged 18-40 or 2) aged >40yr.
Who cannot join
- for females, being pregnant
- Having had X-ray procedures using contrast material in the previous 3 days
- Having medical devices that interfere with scan accuracy
- Wearing external metal objects that cannot be removed
- Having internal metal objects
- Body mass of > 450 lbs.
- Having ostomies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Women's Health and Exercise Laboratories, The Pennsylvania State University
University Park, Pennsylvania, 16802
Mary Jane De Souza, PhD, 814-863-0045, mjd34@psu.edu
Nancy I Williams, Sc.D.
About this study
Official title: Precision and Reliability of Dual X-ray Absorptiometry (DXA) Testing
The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner.
Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess:
Read more
- Within- and between-day variability of testing
- Within- and between-technician variability of testing
- Variability due to positioning and post-scan processing
- Variability due to different DXA scanning equipment
Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults.
Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications.
Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.
Read the detailed description
Osteoporosis and obesity are highly prevalent and disabling chronic diseases. Osteoporosis is a disease of low bone mass, which predisposes people to bone fragility and increased risk of bone fractures. Obesity is a disease characterized by excess body fat levels, which predisposes people to diabetes, heart disease, stroke, hypertension, cancer, sleep apnea, osteoarthritis, and gallbladder disease.
An essential component to research on the prevention and treatment of osteoporosis and obesity is a valid method for monitoring body fat levels and bone mineral density. Dual energy X-ray absorptiometry (DXA) is a method for analyzing bone mineral density and body composition, particularly bone mineral content, fat mass and lean mass in children and adults. DXA scanners use an X-ray tube to produce radiation, which is then filtered into low- and high-energy beams. These beams of radiation are emitted from beneath a table that the supine human body is lying on. The arm, which passes above the person, detects the attenuation of the radiation for each pixel the body occupies. Based on known attenuation levels of different human tissues, the imaging software provides information on the composition of each pixel of the body. These pixels are then summed to provide information on: total body bone mineral content, total bone mineral density, fat mass, and lean mass. The DXA can also assess regional body composition (e.g. trunk fat), which is of importance in evaluating health effects of body fatness patterns. Using standard protocols, bone mineral content and density can be assessed in areas of the body indicating high risk of fractures (e.g. hip and lumbar spine) or areas that are likely to be responsive to dietary or physical activity manipulations (e.g. lumbar spine and radius).
Peripheral quantitative computed tomography (pQCT) is a 3-dimensional imaging technique that goes beyond the 2-dimensional imaging of DXA to assess both true volumetric bone density and bone geometry, the two key components of bone strength. Additionally, it can divide bone into its component parts, i.e. separately assessing bone density and bone geometry of cortical and trabecular bone. As such, the measurements obtained from pQCT provides a more complete picture of what may be occurring within bone tissue that contributes to either bone gain or bone loss, depending on the population and question of interest. pQCT assesses parameters of bone strength at the radius (forearm) and tibia (lower leg).
A vital component of any clinical and research program is precision testing, which assesses the reproducibility of DXA and pQCT measurements within an individual technician and/or between multiple technicians. This study was designed to address our facility's needs and ethical requirement to complete precision testing. This precision testing is a necessary component of verifying the feasibility and validity of the method, as well as cross-calibrating DXA scanners in our multi-site studies. We are completing this testing with the two DXA scanners, the GE Lunar iDXA and the Hologic Horizon W DXA, as well as with the Stratec XCT 3000 pQCT.
A vital component of any clinical and research program is precision testing, which assesses the reproducibility of DXA measurements within an individual technician and/or between multiple technicians. As alluded to above, the validity of bone and soft tissue measurements by DXA and pQCT is related to the skill of the technician in: 1) properly positioning the person before scanning and 2) properly analyzing the scan images afterward. Both of these components are subjective, requiring experience and feedback to improve technique.
From an ethical standpoint, a level of technician competency is important in ensuring that both research volunteers and the technician are not exposed to radiation without the benefit of acceptable scan results. From a clinical and research standpoint, understanding the inherent variability in testing is an important component in planning and executing research studies having bone or body fat outcomes. As described the Conference of Radiation Control Program Directors, Inc. (CRCPD), and as established by the International Society of Bone Densitometry (ISCD), measurement of precision is a key component for assessing:
- The smallest change (least significant change, LSC) in bone density that is biologically significant
- The time interval between measurements necessary to detect changes.
Precision testing requires that multiple scans be completed on individuals representative of the primary target population of interest, sometimes within a fairly short period of time. This exposure of additional radiation to a select group of individuals has created controversy about whether precision testing is necessary and ethical. The CRCPD and ISCD has fully supported precision testing, and recommended that it be a routine practice in all DXA sites. The CRCPD states that, "Some states without understanding the need for precision testing have prohibited the measurement despite low radiation doses and limited numbers of repeat densitometry determinations. Their major concern, of course, is the apparent unnecessary radiation to a few, select patients. To address the benefit versus risk issue, those exposed to the additional, small amount of radiation (equal to approximately an additional 6-12 hours of background radiation) are providing a benefit to themselves and all others by validating the results of bone mineral density (BMD) exams for that facility. Without precision testing, the BMD study is of no value resulting in thousands of patients being exposed to unnecessary radiation."
- Conditions
- Bone and Bones, Body Composition
- Being tested
- DXA and pQCT precision testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA and pQCT precision testingDevice
The participants are only being observed; there is no intervention other than DXA and pQCT testing for the purposes of looking at instrument/technician precision..
| Study group | Role | What they receive |
|---|---|---|
| Men and women aged 18+ | Men and women over the age of 18 Receives: Device: DXA and pQCT precision testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision of iDXA BMD
Standard Deviation and coefficient of variation for BMD measurements obtained on the GE Lunar iDXA
Measured: One month
Precision of Hologic Horizon W DXA BMD
Standard Deviation and coefficient of variation for BMD measurements obtained on the Hologic Horizon W
Measured: One month
Precision of iDXA Body Composition
Standard Deviation and coefficient of variation for body composition measurements obtained on the GE Lunar iDXA
Measured: One month
Precision of Hologic Horizon W DXA Body Composition
Standard Deviation and coefficient of variation for body composition measurements obtained on the Hologic Horizon W
Measured: One month
Precision of the Stratec XCT 3000 pQCT
Standard deviation and coefficient of variation for bone density, geometry, and estimated bone strength for the Stratec XCT 3000 pQCT
Measured: One month
Secondary outcomes (5)
LSC for the iDXA BMD
Least significant change for BMD using the GE Lunar iDXA
Measured: One month
LSC for the Hologic Horizon W BMD
Least significant change for BMD using the Hologic Horizon W DXA
Measured: One month
LSC for the iDXA body composition
Least significant change for body composition using the GE Lunar iDXA
Measured: One month
LSC for the Hologic Horizon W body composition
Least significant change for body composition using the Hologic Horizon W DXA
Measured: One month
LSC for the Stratec XCT 3000
Least significant change for bone density, geometry, and estimated bone strength for the Stratec XCT 3000
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start16 Jun 2008
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and BonesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Jane DeSouza, Penn State University
- Investigators
- Mary Jane De Souza, PhD, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621306
- Sponsor's protocol ID
- DXAPrecision
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision and Reliability of Dual X-ray Absorptiometry (DXA) Testing
- ClinicalTrials.gov ID
- NCT03621306
- Acronym / sponsor ID
- DXAPrecision
- Conditions
- Bone and Bones, Body Composition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 16 Jun 2008 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner.
Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess:
- Within- and between-day variability of testing
- Within- and between-technician variability of testing
- Variability due to positioning and post-scan processing
- Variability due to different DXA scanning equipment
Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults.
Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications.
Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.
Detailed description
Osteoporosis and obesity are highly prevalent and disabling chronic diseases. Osteoporosis is a disease of low bone mass, which predisposes people to bone fragility and increased risk of bone fractures. Obesity is a disease characterized by excess body fat levels, which predisposes people to diabetes, heart disease, stroke, hypertension, cancer, sleep apnea, osteoarthritis, and gallbladder disease.
An essential component to research on the prevention and treatment of osteoporosis and obesity is a valid method for monitoring body fat levels and bone mineral density. Dual energy X-ray absorptiometry (DXA) is a method for analyzing bone mineral density and body composition, particularly bone mineral content, fat mass and lean mass in children and adults. DXA scanners use an X-ray tube to produce radiation, which is then filtered into low- and high-energy beams. These beams of radiation are emitted from beneath a table that the supine human body is lying on. The arm, which passes above the person, detects the attenuation of the radiation for each pixel the body occupies. Based on known attenuation levels of different human tissues, the imaging software provides information on the composition of each pixel of the body. These pixels are then summed to provide information on: total body bone mineral content, total bone mineral density, fat mass, and lean mass. The DXA can also assess regional body composition (e.g. trunk fat), which is of importance in evaluating health effects of body fatness patterns. Using standard protocols, bone mineral content and density can be assessed in areas of the body indicating high risk of fractures (e.g. hip and lumbar spine) or areas that are likely to be responsive to dietary or physical activity manipulations (e.g. lumbar spine and radius).
Peripheral quantitative computed tomography (pQCT) is a 3-dimensional imaging technique that goes beyond the 2-dimensional imaging of DXA to assess both true volumetric bone density and bone geometry, the two key components of bone strength. Additionally, it can divide bone into its component parts, i.e. separately assessing bone density and bone geometry of cortical and trabecular bone. As such, the measurements obtained from pQCT provides a more complete picture of what may be occurring within bone tissue that contributes to either bone gain or bone loss, depending on the population and question of interest. pQCT assesses parameters of bone strength at the radius (forearm) and tibia (lower leg).
A vital component of any clinical and research program is precision testing, which assesses the reproducibility of DXA and pQCT measurements within an individual technician and/or between multiple technicians. This study was designed to address our facility's needs and ethical requirement to complete precision testing. This precision testing is a necessary component of verifying the feasibility and validity of the method, as well as cross-calibrating DXA scanners in our multi-site studies. We are completing this testing with the two DXA scanners, the GE Lunar iDXA and the Hologic Horizon W DXA, as well as with the Stratec XCT 3000 pQCT.
A vital component of any clinical and research program is precision testing, which assesses the reproducibility of DXA measurements within an individual technician and/or between multiple technicians. As alluded to above, the validity of bone and soft tissue measurements by DXA and pQCT is related to the skill of the technician in: 1) properly positioning the person before scanning and 2) properly analyzing the scan images afterward. Both of these components are subjective, requiring experience and feedback to improve technique.
From an ethical standpoint, a level of technician competency is important in ensuring that both research volunteers and the technician are not exposed to radiation without the benefit of acceptable scan results. From a clinical and research standpoint, understanding the inherent variability in testing is an important component in planning and executing research studies having bone or body fat outcomes. As described the Conference of Radiation Control Program Directors, Inc. (CRCPD), and as established by the International Society of Bone Densitometry (ISCD), measurement of precision is a key component for assessing:
- The smallest change (least significant change, LSC) in bone density that is biologically significant
- The time interval between measurements necessary to detect changes.
Precision testing requires that multiple scans be completed on individuals representative of the primary target population of interest, sometimes within a fairly short period of time. This exposure of additional radiation to a select group of individuals has created controversy about whether precision testing is necessary and ethical. The CRCPD and ISCD has fully supported precision testing, and recommended that it be a routine practice in all DXA sites. The CRCPD states that, "Some states without understanding the need for precision testing have prohibited the measurement despite low radiation doses and limited numbers of repeat densitometry determinations. Their major concern, of course, is the apparent unnecessary radiation to a few, select patients. To address the benefit versus risk issue, those exposed to the additional, small amount of radiation (equal to approximately an additional 6-12 hours of background radiation) are providing a benefit to themselves and all others by validating the results of bone mineral density (BMD) exams for that facility. Without precision testing, the BMD study is of no value resulting in thousands of patients being exposed to unnecessary radiation."
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men and women aged 18+ | – | Device: DXA and pQCT precision testingMen and women over the age of 18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers will include men and women of all ages. Women must not be pregnant.
Key inclusion criteria (1 listed)
- Healthy adults of two age groups, 1) aged 18-40 or 2) aged >40yr.
Key exclusion criteria (7 listed)
- for females, being pregnant
- Having had X-ray procedures using contrast material in the previous 3 days
- Having medical devices that interfere with scan accuracy
- Wearing external metal objects that cannot be removed
- Having internal metal objects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXA and pQCT precision testingThe participants are only being observed; there is no intervention other than DXA and pQCT testing for the purposes of looking at instrument/technician precision.. | Device | Men and women aged 18+ |
Primary outcome
Precision of iDXA BMD
Time frame: One month
Standard Deviation and coefficient of variation for BMD measurements obtained on the GE Lunar iDXA
Precision of Hologic Horizon W DXA BMD
Time frame: One month
Standard Deviation and coefficient of variation for BMD measurements obtained on the Hologic Horizon W
Precision of iDXA Body Composition
Time frame: One month
Standard Deviation and coefficient of variation for body composition measurements obtained on the GE Lunar iDXA
Precision of Hologic Horizon W DXA Body Composition
Time frame: One month
Standard Deviation and coefficient of variation for body composition measurements obtained on the Hologic Horizon W
Precision of the Stratec XCT 3000 pQCT
Time frame: One month
Standard deviation and coefficient of variation for bone density, geometry, and estimated bone strength for the Stratec XCT 3000 pQCT
5 secondary outcomes
LSC for the iDXA BMD
Time frame: One month
LSC for the Hologic Horizon W BMD
Time frame: One month
LSC for the iDXA body composition
Time frame: One month
LSC for the Hologic Horizon W body composition
Time frame: One month
LSC for the Stratec XCT 3000
Time frame: One month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Jane De Souza, PhD principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Bones and Body Composition, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Jane De Souza, PhD (814-863-0045, mjd34@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision of iDXA BMD (time frame: One month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.