Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
ADIMOS
2 other identifiers
observational
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 17, 2017
CompletedStudy Start
First participant enrolled
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2021
CompletedNovember 4, 2022
November 1, 2020
2.7 years
July 13, 2017
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone marrow fat content at lumbar spine
Total bone marrow fat content (percentage) at lumbar spine (L1-L4) measured with magnetic resonance imaging
24 months
Secondary Outcomes (3)
Bone marrow fat content at total hip
24 months
Bone mineral density at lumbar spine
24 months
Bone mineral density at total hip
24 months
Study Arms (2)
Group 1 (cases)
occurence of incident major osteoporotic fracture less than 12 weeks
Group 2 (controls)
no history of fragility fracture
Interventions
MRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence.
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
Eligibility Criteria
Post-menopausal women
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Roger Salengro, CHU
Lille, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien Paccou, MD, PhD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 17, 2017
Study Start
October 16, 2018
Primary Completion
June 25, 2021
Study Completion
June 25, 2021
Last Updated
November 4, 2022
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share