ADIMOS: Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 (cases) occurence of incident major osteoporotic fracture less than 12 weeks |
Device: Dixon Magnetic Resonance Imaging
MRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence.
|
| Group 2 (controls) no history of fragility fracture |
Device: dual-energy X-ray absorptiometry (DXA)
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
|
Outcome Measures
Primary Outcome Measures
- Bone marrow fat content at lumbar spine [24 months]
Total bone marrow fat content (percentage) at lumbar spine (L1-L4) measured with magnetic resonance imaging
Secondary Outcome Measures
- Bone marrow fat content at total hip [24 months]
Total bone marrow fat content (percentage) at total hip measured with magnetic resonance imaging
- Bone mineral density at lumbar spine [24 months]
Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA
- Bone mineral density at total hip [24 months]
Bone mineral density (g/cm2) at total hip measured by DXA
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
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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:
- 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.
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body mass index [BMI] >38 kg/m2, weight >140 kg
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Disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or PTH), hormone therapy.
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Chronic kidney disease with DFG <30 ml/mn
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Roger Salengro, CHU | Lille | France |
Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Julien Paccou, MD, PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016_44
- 2017-A00472-51