ObesityPPVS-obNCT04301427
Smallest Significant Value in Osteodensitomery in an Obese Population
A study testing Bone mineral density in people with Obesity, run by CHU de Reims at 1 site in France.
Trial summary
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI. Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Bone mineral density
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2019to 31 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients
- Patients referred to the CHU of Reims to make an osteodensitometric evaluation of their bone mineral density
- BMI > 30 kg/cm²
- Patient affiliated to a health insurance plan
- Patients who have signed informed consent
Who cannot join
- Minor patients
- Pregnant women
- Patients protected by the law
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI.
Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined.
Our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.
Read the detailed description
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population.
There will be at least 120 patient included. The study population will be divided in 3 groups according to their BMI : the first group has a BMI between 30 and 35 kg/cm² ; the second group has a BMI between 35 et 40 kg/cm² ; and the third group has a BMI over 40 kg/cm².
Patients will be referred by their doctors (rheumatologist and others) to evaluate their bone mineral density in osteodensitometry at CHU of Reims. Patients will be informed of the aim of the study by the prescriptor of the osteodensitometry.
The osteodensitometry will be executed by a nurse. Patients will have to complete a questionnaire about their medical history and their medications.
Bone mineral density will be measured twice in osteodensitometry, at the lumbar spine, the hip and the femur. This exam lasts approximately 40 minutes.
Then the smallest significant value will be determined by comparing each measure for every patients.
- Conditions
- Obesity
- Being tested
- Bone mineral density
- Keywords
- Bone density, Osteoporosis, Osteopenia, Obesity, OSteodensitometry
- Medical subject headings
- Obesity, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone mineral densityOther
Bone mineral density will be measured twice in all included patients.
| Study group | Role | What they receive |
|---|---|---|
| Obese patient | Other | Not described Receives: Other: Bone mineral density |
What is being measured
The primary outcome is the main question the study is designed to answer.
osteodensitometry in obese population
smallest significant value in osteodensitometry in obese population
Measured: Day 1
Secondary outcomes (3)
osteodensitometry in obese population with BMI between 30 and 35 kg/cm²
smallest significant value in osteodensitometry in obese population with BMI between 30 et 35 kg/cm²
Measured: Day 1
osteodensitometry in obese population with BMI between 35 and 40 kg/cm²
smallest significant value in osteodensitometry in obese population with BMI between 35 et 40 kg/cm²
Measured: Day 1
osteodensitometry in obese population with BMI over 40 kg/cm²
Smallest significant value in osteodensitometry in obese population with BMI over 40 kg/cm²
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 Nov 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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 ObesityStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301427
- Sponsor's protocol ID
- PO20019
- Acronym
- PPVS-ob
- Status last verified
- Sep 2020
- First submitted
- 6 Mar 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dorilleau C, Kanagaratnam L, Charlot I, Hittinger A, Bertin E, Salmon JH, Geoffroy M. "The least significant change on bone mineral density scan increased in patients with higher degrees of obesity". Aging Clin Exp Res. 2024 Apr 23;36(1):98. doi: 10.1007/s40520-024-02736-4.
PubMed 38652346
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smallest Significant Value in Osteodensitomery in an Obese Population
- ClinicalTrials.gov ID
- NCT04301427
- Acronym / sponsor ID
- PPVS-ob / PO20019
- Conditions
- Obesity
- Keywords
- Bone density, Osteoporosis, Osteopenia, Obesity, OSteodensitometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 10 Mar 2020 (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 aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI.
Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined.
Our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.
Detailed description
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population.
There will be at least 120 patient included. The study population will be divided in 3 groups according to their BMI : the first group has a BMI between 30 and 35 kg/cm² ; the second group has a BMI between 35 et 40 kg/cm² ; and the third group has a BMI over 40 kg/cm².
Patients will be referred by their doctors (rheumatologist and others) to evaluate their bone mineral density in osteodensitometry at CHU of Reims. Patients will be informed of the aim of the study by the prescriptor of the osteodensitometry.
The osteodensitometry will be executed by a nurse. Patients will have to complete a questionnaire about their medical history and their medications.
Bone mineral density will be measured twice in osteodensitometry, at the lumbar spine, the hip and the femur. This exam lasts approximately 40 minutes.
Then the smallest significant value will be determined by comparing each measure for every patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patient | Other | Other: Bone mineral density |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major patients
- Patients referred to the CHU of Reims to make an osteodensitometric evaluation of their bone mineral density
- BMI > 30 kg/cm²
- Patient affiliated to a health insurance plan
- Patients who have signed informed consent
Key exclusion criteria (3 listed)
- Minor patients
- Pregnant women
- Patients protected by the law
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 |
|---|---|---|
| Bone mineral densityBone mineral density will be measured twice in all included patients. | Other | Obese patient |
Primary outcome
osteodensitometry in obese population
Time frame: Day 1
smallest significant value in osteodensitometry in obese population
3 secondary outcomes
osteodensitometry in obese population with BMI between 30 and 35 kg/cm²
Time frame: Day 1
osteodensitometry in obese population with BMI between 35 and 40 kg/cm²
Time frame: Day 1
osteodensitometry in obese population with BMI over 40 kg/cm²
Time frame: Day 1
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 21 Jan 2026.
- Background: PubMed 38652346Dorilleau C, Kanagaratnam L, Charlot I, Hittinger A, Bertin E, Salmon JH, Geoffroy M. "The least significant change on bone mineral density scan increased in patients with higher degrees of obesity". Aging Clin Exp Res. 2024 Apr 23;36(1):98. doi: 10.1007/s40520-024-02736-4.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone mineral density in people with Obesity, run by CHU de Reims 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 5 inclusion and 3 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 21 Jan 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 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?
osteodensitometry in obese population (time frame: Day 1). 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 NCT04301427, 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 21 Jan 2026.