Fractures, BoneADIMOSNCT03219125
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
An observational study of Fractures, Bone and Bone Marrow Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
The purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fractures, Bone, Bone Marrow Disease, Fat Disorder
- What is being tested?
- Dixon Magnetic Resonance Imaging and dual-energy X-ray absorptiometry (DXA)
- Type of treatment
- Medical device
- How many people
- 203 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 25 Jun 2021
- Phase
- Observational
- 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 50 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post-menopausal women
Who may be able to join
- post-menopausal women : 50-90 years old
- Group 1 (cases) : occurence of incident major osteoporotic fracture less than 12 months
- Group 2 (controls) : no history of fragility fracture
Who cannot join
- Implants that are contraindicated for the magnetic resonance (MR) examination.
- Implants that might create a health risk or other problem during an MR exam include: 1) cardiac pacemaker or implantable defibrillator, 2) catheter that has metal components that may pose a risk of a burn injury, 3) a ferromagnetic metal clip placed to prevent bleeding from an intracranial aneurysm, 4) an implanted medication pump (such as that used to deliver insulin or a pain-relieving drug), and 5) a cochlear implant.
- body mass index [BMI] >38 kg/m2, weight >140 kg
- Disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or PTH), hormone therapy.
- Chronic kidney disease with DFG <30 ml/mn
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
The purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.
- Conditions
- Fractures, Bone, Bone Marrow Disease, Fat Disorder, Adiposity
- Being tested
- Dixon Magnetic Resonance Imaging, dual-energy X-ray absorptiometry (DXA)
- Keywords
- marrow adipose tissue, bone marrow adiposity
- Medical subject headings
- Fractures, Bone, Bone Marrow Diseases, Lipid Metabolism Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dixon Magnetic Resonance ImagingDevice
MRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence.
dual-energy X-ray absorptiometry (DXA)Device
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (cases) | occurence of incident major osteoporotic fracture less than 12 weeks Receives: Device: Dixon Magnetic Resonance Imaging | |
| Group 2 (controls) | no history of fragility fracture Receives: Device: dual-energy X-ray absorptiometry (DXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone marrow fat content at lumbar spine
Total bone marrow fat content (percentage) at lumbar spine (L1-L4) measured with magnetic resonance imaging
Measured: 24 months
Secondary outcomes (3)
Bone marrow fat content at total hip
Total bone marrow fat content (percentage) at total hip measured with magnetic resonance imaging
Measured: 24 months
Bone mineral density at lumbar spine
Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA
Measured: 24 months
Bone mineral density at total hip
Bone mineral density (g/cm2) at total hip measured by DXA
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start16 Oct 2018
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Paccou, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219125
- Sponsor's protocol ID
- 2016_44
- Other IDs
- 2017-A00472-51
- Acronym
- ADIMOS
- Status last verified
- Nov 2020
- First submitted
- 13 Jul 2017
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
- ClinicalTrials.gov ID
- NCT03219125
- Acronym / sponsor ID
- ADIMOS / 2016_44
- Conditions
- Fractures, Bone, Bone Marrow Disease, Fat Disorder, Adiposity
- Keywords
- marrow adipose tissue, bone marrow adiposity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 17 Jul 2017 (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 is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (cases) | – | Device: Dixon Magnetic Resonance Imagingoccurence of incident major osteoporotic fracture less than 12 weeks |
| Group 2 (controls) | – | Device: dual-energy X-ray absorptiometry (DXA)no history of fragility fracture |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal women
Key inclusion criteria (3 listed)
- post-menopausal women : 50-90 years old
- Group 1 (cases) : occurence of incident major osteoporotic fracture less than 12 months
- Group 2 (controls) : no history of fragility fracture
Key exclusion criteria (5 listed)
- Implants that are contraindicated for the magnetic resonance (MR) examination.
- Implants that might create a health risk or other problem during an MR exam include: 1) cardiac pacemaker or implantable defibrillator, 2) catheter that has metal components that may pose a risk of a burn injury, 3) a ferromagnetic metal clip placed to prevent bleeding from an intracranial aneurysm, 4) an implanted medication pump (such as that used to deliver insulin or a pain-relieving drug), and 5) a cochlear implant.
- body mass index [BMI] >38 kg/m2, weight >140 kg
- Disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or PTH), hormone therapy.
- Chronic kidney disease with DFG <30 ml/mn
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 |
|---|---|---|
| Dixon Magnetic Resonance ImagingMRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence. | Device | Group 1 (cases) |
| dual-energy X-ray absorptiometry (DXA)Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density. | Device | Group 2 (controls) |
Primary outcome
Bone marrow fat content at lumbar spine
Time frame: 24 months
Total bone marrow fat content (percentage) at lumbar spine (L1-L4) measured with magnetic resonance imaging
3 secondary outcomes
Bone marrow fat content at total hip
Time frame: 24 months
Bone mineral density at lumbar spine
Time frame: 24 months
Bone mineral density at total hip
Time frame: 24 months
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 4 Nov 2022.
- 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. This study is not recruiting at the moment.
Julien Paccou, MD, PhD principal investigator
University Hospital, Lille
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 Fractures, Bone and Bone Marrow Disease, run by University Hospital, Lille 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 5 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 4 Nov 2022. 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?
Bone marrow fat content at lumbar spine (time frame: 24 months). 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 4 Nov 2022.