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临床试验/NCT06541548
NCT06541548
招募中
不适用

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

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 1,000 人2026年2月2日

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.

注册库
clinicaltrials.gov
开始日期
2026年2月2日
结束日期
2035年5月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

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)

研究点 (1)

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