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Clinical Trials/NCT03219125
NCT03219125CompletedNot Applicable

Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study

University Hospital, Lille1 site in 1 country203 target enrollmentStarted: October 16, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
203
Locations
1
Primary Endpoint
Bone marrow fat content at lumbar spine
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Bone mineral density at lumbar spine(24 months)
  • Bone marrow fat content at total hip(24 months)
  • Bone mineral density at total hip(24 months)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Bone Marrow Adiposity and Fragility... | Clinical Trial