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Completed

NCT Number: NCT03219125

Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women

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.

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Key information

Conditions

Fractures, Bone Adiposity Body Weight Bone Marrow Disease Bone Marrow Diseases Fat Disorder Hematologic Diseases Hemic and Lymphatic Diseases Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

50 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dixon Magnetic Resonance Imaging

Device

MRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence.

dual-energy X-ray absorptiometry (DXA)

Device

Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ADIMOS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2017
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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