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

November 3, 2022 updated by: University Hospital, Lille

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Roger Salengro, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Post-menopausal women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (cases)
occurence of incident major osteoporotic fracture less than 12 weeks
Device: 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.
Group 2 (controls)
no history of fragility fracture
Device: dual-energy X-ray absorptiometry (DXA)
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone marrow fat content at total hip
Time Frame: 24 months
Total bone marrow fat content (percentage) at total hip measured with magnetic resonance imaging
24 months
Bone mineral density at lumbar spine
Time Frame: 24 months
Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA
24 months
Bone mineral density at total hip
Time Frame: 24 months
Bone mineral density (g/cm2) at total hip measured by DXA
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Julien Paccou, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

June 25, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_44
  • 2017-A00472-51 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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