Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss
NCT Number: NCT06541548
Acronym: MICROS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoporosis Risk|Bone Loss
Interventions: DEVICE: HR-pQCT|DEVICE: pQCT|DEVICE: DEXA
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2034-09
Locations: Chu Saint Etienne, Saint-Étienne, 42055, France

Summary:
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.

Primary Outcome Measures: total volumetric mineral density by HR-pQCT, Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies, Day 1|trabecular volumetric mineral density by HR-pQCT, Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies., Day 1|Cortical volumetric mineral density by HR-pQCT, Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies., Day 1|Describe number of trabeculae by HR-pQCT, Number of trabeculae (1/mm) as a function of pathologies., Day 1|Trabecular thickness by HR-pQCT, Describe trabecular thickness (mm) as a function of pathologies., Day 1|cortical thickness (mm) by HR-pQCT, Describe cortical thickness (mm) as a function of pathologies., Day 1|trabecular separation by HR-pQCT, Describe trabecular separation (mm) as a function of pathologies., Day 1|cortical porosity by HR-pQCT, Describe cortical porosity (%) as a function of pathologies., Day 1
Secondary Outcome Measures: Total bone mineral content with pQCT, Total bone mineral content (mg), Day 1|Total bone surface with pQCT, Total bone surface (mm2), Day 1|Total bone density with pQCT, Total bone density (mg/mm3), Day 1|Cortical and trabecular density with pQCT, Cortical and trabecular density (mg/mm3), Day 1|bone resistance index with pQCT, bone resistance index (g2/mm), Day 1|Bone density by DEXA, Parameter measured by DEXA is Bone Mineral Density (BMD, g/cm2)., Day 1|volumetric mineral density with HR-PQCT, Total volumetric mineral density (mg/ccm HA), Day 1|Trabecular volumetric mineral density with HR-PQCT, Trabecular volumetric mineral density (mg/ccm HA), Day 1|Cortical volumetric mineral density with HR-PQCT, Cortical volumetric mineral density (mg/ccm HA)., Day 1