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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219125
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date July 13, 2017
First Posted Date July 17, 2017
Last Update Posted Date December 4, 2019
Actual Study Start Date October 16, 2018
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 13, 2017)
  • 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
  • Bone mineral density at lumbar spine [ Time Frame: 24 months ]
    Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA
  • Bone mineral density at total hip [ Time Frame: 24 months ]
    Bone mineral density (g/cm2) at total hip measured by DXA
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Official Title Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Post-menopausal women
Condition
  • Fractures, Bone
  • Bone Marrow Disease
  • Fat Disorder
  • Adiposity
Intervention
  • 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.
  • Device: dual-energy X-ray absorptiometry (DXA)
    Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
Study Groups/Cohorts
  • Group 1 (cases)
    occurence of incident major osteoporotic fracture less than 12 weeks
    Intervention: Device: Dixon Magnetic Resonance Imaging
  • Group 2 (controls)
    no history of fragility fracture
    Intervention: Device: dual-energy X-ray absorptiometry (DXA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2017)
194
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Julien Paccou, MD, PhD 3 20 44 69 26 ext +33 julien.paccou@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03219125
Other Study ID Numbers 2016_44
2017-A00472-51 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Julien Paccou, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date December 2019