OsteodensitometryNCT02965742
Clinical Evaluation Of An X-Ray Bone Densitometer:Use Of DXA Technology For Precise Assessment Of Human Body Composition
A study testing Stratos, "Hologic QDR 4500A" and "Hologic HORIZON A" in people with Osteodensitometry, run by Diagnostic Medical Systems at 1 site in France.
Trial summary
The main objectives of this study are: to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteodensitometry
- What is being tested?
- Stratos, "Hologic QDR 4500A" and "Hologic HORIZON A"
- 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
- Feb 2016to Jan 2020
- 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
- Healthy volunteers accepted
- 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 or sportsmen coming through a protocol where the nuclear medicine department is the investigator center
Who cannot join
- The patient is pregnant or nursing
- The patient is unable to sign or refuse to sign the informed consent
- The patient has a coronary stent or metal sutures in the heart
- The patient has any type of metal objects in the body such as an artificial joint, a pin or a metal plate
- The patient has a pacemaker or defibrillator
- Patient weighing more than 200 kg or more than 2 meters high by 65 centimeters wide
Show all 10Show fewer
- The patient is using an insulin pump or with insulin-necked
- The patient has undergone X-ray examination using a contrast medium such as barium in the previous seven days visit,
- Patient who underwent an examination using x rays in the 15 days preceding the visit
- Patient suffering from generalized edema
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, Hérault, 34295
Laurent MAIMOUN, Phd, 0467338464 ext. +33, l-maimoun@chu-montpellier.fr
Denis MARIANO-GOULART, Phd.Medecine
About this study
Official title: Clinical Evaluation Of An X-Ray Bone Densitometer: Use Of DXA Technology For Precise Assessment Of Body Composition In Humans
The main objectives of this study are:
- to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.
- to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.
Read the detailed description
The secondary objectives of this study are:
- the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic 4500 A,
- the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic HORIZON A,
- Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic QDR 4500A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms,
- Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic HORIZON A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms.
- Conditions
- Osteodensitometry
- Being tested
- Stratos, "Hologic QDR 4500A", "Hologic HORIZON A"
- Keywords
- DXA, DMS, DMS Imaging, STRATOS, Horizon A, QDR4500A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StratosDevice
A machine made by DMS group.
"Hologic QDR 4500A"Device
A machine made by Hologic inc.
"Hologic HORIZON A"Device
A machine made by Hologic inc.
| Study group | Role | What they receive |
|---|---|---|
| The study population: first 25 patients | Experimental | The study population consists of patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A" Receives: Device: Stratos; Device: "Hologic QDR 4500A"; Device: "Hologic HORIZON A" |
| The study population: last 25 patients | Experimental | The study population consists of sportsmen patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination.
Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A" Receives: Device: Stratos; Device: "Hologic QDR 4500A"; Device: "Hologic HORIZON A" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lin concordance coefficient
In order to get a first idea of the adequacy of the two techniques measurements of the two bone densitometers, a calculation of intraclass correlation coefficients will be done. To supplement this data, a correlation study between the two techniques will be performed. For this we will use the Bland-Altman technique and a study of LIN concordance correlation 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 posted17 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteodensitometryStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Diagnostic Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Montpellier
- Responsible party
- Sponsor
- Investigators
- Denis MARIANO-GOULART, Phd.Medecine, Principal investigator, Nuclear department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965742
- Sponsor's protocol ID
- 2015-A00596-43
- Status last verified
- Mar 2019
- First submitted
- 10 Nov 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Of An X-Ray Bone Densitometer: Use Of DXA Technology For Precise Assessment Of Body Composition In Humans
- ClinicalTrials.gov ID
- NCT02965742
- Acronym / sponsor ID
- 2015-A00596-43
- Conditions
- Osteodensitometry
- Keywords
- DXA, DMS, DMS Imaging, STRATOS, Horizon A, QDR4500A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diagnostic Medical SystemsIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Montpellier
- Study start
- Feb 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Nov 2016 (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 objectives of this study are:
- to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.
- to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.
Detailed description
The secondary objectives of this study are:
- the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic 4500 A,
- the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic HORIZON A,
- Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic QDR 4500A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms,
- Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic HORIZON A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms.
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 25 patients | Experimental | Device: Stratos, Device: "Hologic QDR 4500A", Device: "Hologic HORIZON A"The study population consists of patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A" |
| The study population: last 25 patients | Experimental | Device: Stratos, Device: "Hologic QDR 4500A", Device: "Hologic HORIZON A"The study population consists of sportsmen patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 or sportsmen coming through a protocol where the nuclear medicine department is the investigator center
Key exclusion criteria (10 listed)
- The patient is pregnant or nursing
- The patient is unable to sign or refuse to sign the informed consent
- The patient has a coronary stent or metal sutures in the heart
- The patient has any type of metal objects in the body such as an artificial joint, a pin or a metal plate
- The patient has a pacemaker or defibrillator
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 |
|---|---|---|
| StratosA machine made by DMS group. | Device | The study population: first 25 patients, The study population: last 25 patients |
| "Hologic QDR 4500A"A machine made by Hologic inc. | Device | The study population: first 25 patients, The study population: last 25 patients |
| "Hologic HORIZON A"A machine made by Hologic inc. | Device | The study population: first 25 patients, The study population: last 25 patients |
Primary outcome
Lin concordance coefficient
Time frame: Day 0
In order to get a first idea of the adequacy of the two techniques measurements of the two bone densitometers, a calculation of intraclass correlation coefficients will be done. To supplement this data, a correlation study between the two techniques will be performed. For this we will use the Bland-Altman technique and a study of LIN concordance correlation coefficient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: Undecided
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.
Denis MARIANO-GOULART, Phd.Medecine principal investigator
Nuclear department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratos, "Hologic QDR 4500A" and "Hologic HORIZON A" in people with Osteodensitometry, run by Diagnostic Medical Systems 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: status not confirmed, as of the sponsor's last update on 14 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent MAIMOUN, Phd. (0467338464 ext. +33, l-maimoun@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lin concordance coefficient (time frame: Day 0). 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 14 Mar 2019.