Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss
- Conditions
- Bone LossOsteoporosis Risk
- Interventions
- Device: HR-pQCTDevice: pQCTDevice: DEXA
- Registration Number
- NCT06541548
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
For the patients:
Women or men treated at the Saint-Etienne University Hospital and presenting an osteoporotic risk with one of the following associated pathologies:
-
Osteoporosis defined by: History of a documented brittle bone fracture
-
Bone fragility: Patient with indication for bone densitometry but no history of fracture
-
Inflammatory joint disease:
- Rheumatoid arthritis
- Spondyloarthritis
-
Chronic kidney disease
-
Endocrinopathies:
- Primary hyperparathyroidism
- Constitutional thinness
- Anorexia nervosa
- Obesity (BMI >30)
- Sarcopenia
-
Neuropathies - Parkinson's disease
For the controls:
Acute episode of spinal or radiculalgia (less than one month old) with corticosteroid treatment of less than 1 month Signature of written consent
- No sign written consent
For the controls:
- Medications inducing bone loss:
- 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)
- History of fracture due to bone fragility
- Taking bone-targeting medication (biphosphonate, teriparatide, strontium ranelate)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group HR-pQCT Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis. Control group DEXA Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis. Patient group DEXA Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis. Patient group HR-pQCT Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis. Patient group pQCT Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis. Control group pQCT Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis.
- Primary Outcome Measures
Name Time Method total volumetric mineral density by HR-pQCT Day 1 Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies
Trabecular thickness by HR-pQCT Day 1 Describe trabecular thickness (mm) as a function of pathologies.
Cortical volumetric mineral density by HR-pQCT Day 1 Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.
Describe number of trabeculae by HR-pQCT Day 1 Number of trabeculae (1/mm) as a function of pathologies.
trabecular separation by HR-pQCT Day 1 Describe trabecular separation (mm) as a function of pathologies.
trabecular volumetric mineral density by HR-pQCT Day 1 Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.
cortical porosity by HR-pQCT Day 1 Describe cortical porosity (%) as a function of pathologies.
cortical thickness (mm) by HR-pQCT Day 1 Describe cortical thickness (mm) as a function of pathologies.
- Secondary Outcome Measures
Name Time Method Total bone density with pQCT Day 1 Total bone density (mg/mm3)
Total bone mineral content with pQCT Day 1 Total bone mineral content (mg)
Total bone surface with pQCT Day 1 Total bone surface (mm2)
Cortical and trabecular density with pQCT Day 1 Cortical and trabecular density (mg/mm3)
bone resistance index with pQCT Day 1 bone resistance index (g2/mm)
Bone density by DEXA Day 1 Parameter measured by DEXA is Bone Mineral Density (BMD, g/cm2).
volumetric mineral density with HR-PQCT Day 1 Total volumetric mineral density (mg/ccm HA)
Trabecular volumetric mineral density with HR-PQCT Day 1 Trabecular volumetric mineral density (mg/ccm HA)
Cortical volumetric mineral density with HR-PQCT Day 1 Cortical volumetric mineral density (mg/ccm HA).
Trial Locations
- Locations (1)
Chu Saint Etienne
🇫🇷Saint-Étienne, France