- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219125
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
-
-
-
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
|
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
|
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
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
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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