Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women

Fractures, Bone Clinical Trial

— ADIMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219125
• Other study ID #: 2016_44
• Secondary ID: 2017-A00472-51
• Status: Completed
• Start date: October 16, 2018
• Est. completion date: June 25, 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Bone Marrow Disease
• Bone Marrow Diseases
• Fat Disorder
• Fractures, Bone
• Obesity

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.
• dual-energy X-ray absorptiometry (DXA)
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bone marrow fat content at total hip	Total bone marrow fat content (percentage) at total hip measured with magnetic resonance imaging	24 months
Secondary	Bone mineral density at lumbar spine	Bone mineral density (g/cm2) at lumbar spine (L1-L4) measured by DXA	24 months
Secondary	Bone mineral density at total hip	Bone mineral density (g/cm2) at total hip measured by DXA	24 months