Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women

Completed

• Conditions: Adiposity; Fractures, Bone; Bone Marrow Disease; Fat Disorder
• Interventions: Device: dual-energy X-ray absorptiometry (DXA); Device: Dixon Magnetic Resonance Imaging

• Registration Number: NCT03219125
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2018-10-16
• Status Verified: 2020-11
• Primary Completion: 2021-06-25
• Study Completion: 2021-06-25
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Bone mineral density at lumbar spine	24 months	Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA
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 total hip	24 months	Bone mineral density (g/cm2) at total hip measured by DXA

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France