Comparison of Bone Microarchitecture Analysed by High Resolution Peripheral Microscanner (HR-pQCT) and Peripheral Microscanner (pQCT) in Pathologies With Bone Loss and/or Muscle Loss
概览
- 阶段
- 不适用
- 干预措施
- HR-pQCT
- 疾病 / 适应症
- Osteoporosis Risk
- 发起方
- Centre Hospitalier Universitaire de Saint Etienne
- 入组人数
- 1000
- 试验地点
- 1
- 主要终点
- total volumetric mineral density by HR-pQCT
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Patient group
Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis.
干预措施: HR-pQCT
Patient group
Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis.
干预措施: pQCT
Patient group
Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis.
干预措施: DEXA
Control group
Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis.
干预措施: HR-pQCT
Control group
Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis.
干预措施: pQCT
Control group
Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis.
干预措施: DEXA
结局指标
主要结局
total volumetric mineral density by HR-pQCT
时间窗: Day 1
Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies
Trabecular thickness by HR-pQCT
时间窗: Day 1
Describe trabecular thickness (mm) as a function of pathologies.
cortical thickness (mm) by HR-pQCT
时间窗: Day 1
Describe cortical thickness (mm) as a function of pathologies.
Cortical volumetric mineral density by HR-pQCT
时间窗: Day 1
Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.
Describe number of trabeculae by HR-pQCT
时间窗: Day 1
Number of trabeculae (1/mm) as a function of pathologies.
trabecular separation by HR-pQCT
时间窗: Day 1
Describe trabecular separation (mm) as a function of pathologies.
trabecular volumetric mineral density by HR-pQCT
时间窗: Day 1
Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.
cortical porosity by HR-pQCT
时间窗: Day 1
Describe cortical porosity (%) as a function of pathologies.
次要结局
- Total bone density with pQCT(Day 1)
- Total bone mineral content with pQCT(Day 1)
- Total bone surface with pQCT(Day 1)
- Cortical and trabecular density with pQCT(Day 1)
- bone resistance index with pQCT(Day 1)
- Bone density by DEXA(Day 1)
- volumetric mineral density with HR-PQCT(Day 1)
- Trabecular volumetric mineral density with HR-PQCT(Day 1)
- Cortical volumetric mineral density with HR-PQCT(Day 1)