About this trial
The study aims to utilize medical devices, such as the Xtreme CT and XCT 3000, to assess bone and muscle microarchitecture for various pathologies. The devices provide crucial data on bone and muscle density, aiding in understanding fracture risks associated with conditions like rheumatoid arthritis and neurological disorders. Current methods like DXA scanning have limitations in predicting fracture risks accurately due to their inability to assess cortical and trabecular microstructure. The study emphasizes the importance of evaluating cortical porosity and trabecular volume loss, especially in conditions like post-menopausal osteoporosis and sarcopenia. Additionally, it explores the impact of neurological disorders, renal insufficiency, and endocrinopathies on bone health. Furthermore, the study aims to establish a control group to differentiate pathological changes from age-related variations. Expected outcomes include a comprehensive understanding of bone microarchitecture alterations across various pathologies and the potential to improve fracture risk estimation beyond conventional methods like DEXA scanning. Ultimately, the study anticipates facilitating better management strategies to reduce fracture risks associated with these conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Osteoporosis defined by: History of a documented brittle bone fracture
Bone fragility: Patient with indication for bone densitometry but no history of fracture
Rheumatoid arthritis
Spondyloarthritis
Disqualifiers
No sign written consent
anti-aromasin or GnRH agonist for at least 6 months,
corticosteroids (dose ≥ 5 mg/d for 6 months)
anti-epileptic drugs: carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months)
Trial design
Parallel
Treatments tested in this trial
HR-pQCT
DeviceXtreme CT® device is a high resolution peripheral quantitative computed tomography (HR-pQCT) used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body. For the study, the device will be used to assess bone density and microarchitecture at the forearm and shin for a systemic effect. In rheumatoid arthritis, bone density and microarchitecture will also be measured at the metacarpophalangeal.
pQCT
DevicePeripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.
DEXA
DeviceThe Lunar Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck.
Treatment groups
Trial outcomes
Primary outcomes
total volumetric mineral density by HR-pQCT
Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies
trabecular volumetric mineral density by HR-pQCT
Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.
Cortical volumetric mineral density by HR-pQCT
Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.
Describe number of trabeculae by HR-pQCT
Number of trabeculae (1/mm) as a function of pathologies.
Secondary outcomes
Total bone mineral content with pQCT
Total bone mineral content (mg)
Total bone surface with pQCT
Total bone surface (mm2)
Total bone density with pQCT
Total bone density (mg/mm3)
Cortical and trabecular density with pQCT
Cortical and trabecular density (mg/mm3)
Sponsors and contacts
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