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Trial record 8 of 1839 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

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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

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.

Condition or disease Intervention/treatment
Fractures, Bone Bone Marrow Disease Fat Disorder Adiposity Device: Dixon Magnetic Resonance Imaging Device: dual-energy X-ray absorptiometry (DXA)

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Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Bone mineral density at lumbar spine [ Time Frame: 24 months ]
    Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA

  3. Bone mineral density at total hip [ Time Frame: 24 months ]
    Bone mineral density (g/cm2) at total hip measured by DXA



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Post-menopausal women
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219125


Contacts
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Contact: Julien Paccou, MD, PhD 3 20 44 69 26 ext +33 julien.paccou@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: Julien Paccou, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Julien Paccou, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03219125     History of Changes
Other Study ID Numbers: 2016_44
2017-A00472-51 ( Other Identifier: ID-RCB number, ANSM )
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
marrow adipose tissue
bone marrow adiposity
Additional relevant MeSH terms:
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Bone Marrow Diseases
Obesity
Fractures, Bone
Wounds and Injuries
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hematologic Diseases