Adiposity Clinical Trial
— ADIMOSOfficial title:
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
Verified date | November 2020 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 203 |
Est. completion date | June 25, 2021 |
Est. primary completion date | June 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 90 Years |
Eligibility | 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: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Roger Salengro, CHU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone marrow fat content at lumbar spine | Total bone marrow fat content (percentage) at lumbar spine (L1-L4) measured with magnetic resonance imaging | 24 months | |
Secondary | Bone marrow fat content at total hip | Total bone marrow fat content (percentage) at total hip measured with magnetic resonance imaging | 24 months | |
Secondary | Bone mineral density at lumbar spine | Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA | 24 months | |
Secondary | Bone mineral density at total hip | Bone mineral density (g/cm2) at total hip measured by DXA | 24 months |
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