Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women

NCT ID: NCT03219125

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-16

Study Completion Date

2021-06-25

Brief Summary

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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

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Conditions

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Fractures, Bone Bone Marrow Disease Fat Disorder Adiposity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 (cases)

occurence of incident major osteoporotic fracture less than 12 weeks

Dixon Magnetic Resonance Imaging

Intervention Type DEVICE

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

dual-energy X-ray absorptiometry (DXA)

Intervention Type DEVICE

Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Interventions

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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.

Intervention Type DEVICE

dual-energy X-ray absorptiometry (DXA)

Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien Paccou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A00472-51

Identifier Type: OTHER

Identifier Source: secondary_id

2016_44

Identifier Type: -

Identifier Source: org_study_id

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