OsteodensitometrySTRATOSNCT02609191
Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry
A study testing Whole body exam using the "Discovery A", First whole body exam using the "Stratos DR" and Second whole body exam using the "Stratos DR" in people with Osteodensitometry, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR: Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteodensitometry
- What is being tested?
- Whole body exam using the "Discovery A", First whole body exam using the "Stratos DR" and Second whole body exam using the "Stratos DR"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is referred by a doctor for the performance of an osteodensitometry examination.
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection or any kind of guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The subject is suffering from a visually significant scoliosis
Show all 10Show fewer
- The patient is pregnant or breastfeeding
- Patient weighing over 160 kg
- Patient having undergone X-ray examination using a contrast medium such as barium in the 7 days preceding the visit
- Patient who underwent an examination using γ rays in the 15 days preceding the visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry: Cross Calibration and Reproducibility Between the "Stratos DR" and "Discovery A" Bone Densitometers
The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:
- Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
- And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.
Read the detailed description
The secondary objective of this study is to cross calibrate the measures of bone mineral content (BMC) and bone mineral density (BMD) from the Stratos DR against those of the Discovery A on the whole body and its subregions.
- Conditions
- Osteodensitometry
- Being tested
- Whole body exam using the "Discovery A", First whole body exam using the "Stratos DR", Second whole body exam using the "Stratos DR"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body exam using the "Discovery A"Device
Whole body exam using the "Discovery A" machine made by Hologic.
First whole body exam using the "Stratos DR"Device
First whole body exam using the "Stratos DR" machine made by the DMS group.
Second whole body exam using the "Stratos DR"Device
Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes.
| Study group | Role | What they receive |
|---|---|---|
| The study population: first 30 patients | Experimental | The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR"
Intervention: Second whole body exam using the "Stratos DR" Receives: Device: Whole body exam using the "Discovery A"; Device: First whole body exam using the "Stratos DR"; Device: Second whole body exam using the "Stratos DR" |
| The study population: last 20 patients | Experimental | The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body exam using the "Discovery A"
Intervention: First whole body exam using the "Stratos DR" Receives: Device: Whole body exam using the "Discovery A"; Device: First whole body exam using the "Stratos DR" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lin concordance coefficient for fat mass
The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.
Measured: Day 0
Lin concordance coefficient for lean mass
The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.
Measured: Day 0
RMS-%CV (root-mean-square coefficient of variation) for total fat mass
Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)
Measured: Day 0
RMS-%CV (root-mean-square coefficient of variation) for total lean mass
Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)
Measured: Day 0
Secondary outcomes (2)
Lin's concordance coefficient for Bone Mineral Content
The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient.
Measured: Day 0
Lin's concordance coefficient for Bone Mineral Density
The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJun 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteodensitometryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- DMS Apelem
- Responsible party
- Sponsor
- Investigators
- Vincent Boudousq, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609191
- Sponsor's protocol ID
- LOCAL/2015/VB-01
- Other IDs
- 2015-A00987-42
- Acronym
- STRATOS
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2015
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Neron M, Fatton B, Monforte M, Mares P, de Tayrac R, Letouzey V. [Evaluation of urine postvoid residuals in post-partum period: a prospective and descriptive clinical study]. Prog Urol. 2015 Mar;25(4):211-6. doi: 10.1016/j.purol.2014.09.043. Epub 2014 Oct 22. French.
PubMed 25450754
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry: Cross Calibration and Reproducibility Between the "Stratos DR" and "Discovery A" Bone Densitometers
- ClinicalTrials.gov ID
- NCT02609191
- Acronym / sponsor ID
- STRATOS / LOCAL/2015/VB-01
- Conditions
- Osteodensitometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- DMS Apelem
- Study start
- Jun 2016
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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 main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:
- Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region).
- And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.
Detailed description
The secondary objective of this study is to cross calibrate the measures of bone mineral content (BMC) and bone mineral density (BMD) from the Stratos DR against those of the Discovery A on the whole body and its subregions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study population: first 30 patients | Experimental | Device: Whole body exam using the "Discovery A", Device: First whole body exam using the "Stratos DR", Device: Second whole body exam using the "Stratos DR"The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body exam using the "Discovery A" Intervention: First whole body exam using the "Stratos DR" Intervention: Second whole body exam using the "Stratos DR" |
| The study population: last 20 patients | Experimental | Device: Whole body exam using the "Discovery A", Device: First whole body exam using the "Stratos DR"The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body exam using the "Discovery A" Intervention: First whole body exam using the "Stratos DR" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is referred by a doctor for the performance of an osteodensitometry examination.
Key exclusion criteria (10 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection or any kind of guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Whole body exam using the "Discovery A"Whole body exam using the "Discovery A" machine made by Hologic. | Device | The study population: first 30 patients, The study population: last 20 patients |
| First whole body exam using the "Stratos DR"First whole body exam using the "Stratos DR" machine made by the DMS group. | Device | The study population: first 30 patients, The study population: last 20 patients |
| Second whole body exam using the "Stratos DR"Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes. | Device | The study population: first 30 patients |
Primary outcome
Lin concordance coefficient for fat mass
Time frame: Day 0
The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.
Lin concordance coefficient for lean mass
Time frame: Day 0
The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient.
RMS-%CV (root-mean-square coefficient of variation) for total fat mass
Time frame: Day 0
Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)
RMS-%CV (root-mean-square coefficient of variation) for total lean mass
Time frame: Day 0
Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry)
2 secondary outcomes
Lin's concordance coefficient for Bone Mineral Content
Time frame: Day 0
Lin's concordance coefficient for Bone Mineral Density
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 25450754Neron M, Fatton B, Monforte M, Mares P, de Tayrac R, Letouzey V. [Evaluation of urine postvoid residuals in post-partum period: a prospective and descriptive clinical study]. Prog Urol. 2015 Mar;25(4):211-6. doi: 10.1016/j.purol.2014.09.043. Epub 2014 Oct 22. French.
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. This study is not recruiting at the moment.
Vincent Boudousq, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body exam using the "Discovery A", First whole body exam using the "Stratos DR" and Second whole body exam using the "Stratos DR" in people with Osteodensitometry, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 19 Nov 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lin concordance coefficient for fat mass (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02609191, which also lists 1 linked publication.
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 19 Nov 2025.