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Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women (ADIMOS)

U

University Hospital, Lille

Status

Completed

Conditions

Bone Marrow Disease
Adiposity
Fat Disorder
Fractures, Bone

Treatments

Device: dual-energy X-ray absorptiometry (DXA)
Device: Dixon Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT03219125
2017-A00472-51 (Other Identifier)
2016_44

Details and patient eligibility

About

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.

Enrollment

203 patients

Sex

Female

Ages

50 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

203 participants in 2 patient groups

Group 1 (cases)
Description:
occurence of incident major osteoporotic fracture less than 12 weeks
Treatment:
Device: Dixon Magnetic Resonance Imaging
Group 2 (controls)
Description:
no history of fragility fracture
Treatment:
Device: dual-energy X-ray absorptiometry (DXA)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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