Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss

Official title

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

Overview

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.

Interventions

• Device HR-pQCT
  Xtreme 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.
• Device pQCT
  Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.
• Device DEXA
  The 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.

Primary outcome measures

• total volumetric mineral density by HR-pQCT [Time frame: Day 1]
• trabecular volumetric mineral density by HR-pQCT [Time frame: Day 1]
• Cortical volumetric mineral density by HR-pQCT [Time frame: Day 1]
• Describe number of trabeculae by HR-pQCT [Time frame: Day 1]
• Trabecular thickness by HR-pQCT [Time frame: Day 1]
• cortical thickness (mm) by HR-pQCT [Time frame: Day 1]
• trabecular separation by HR-pQCT [Time frame: Day 1]
• cortical porosity by HR-pQCT [Time frame: Day 1]

Secondary outcome measures (9)

• Total bone mineral content with pQCT [Time frame: Day 1]
• Total bone surface with pQCT [Time frame: Day 1]
• Total bone density with pQCT [Time frame: Day 1]
• Cortical and trabecular density with pQCT [Time frame: Day 1]
• bone resistance index with pQCT [Time frame: Day 1]
• Bone density by DEXA [Time frame: Day 1]
• volumetric mineral density with HR-PQCT [Time frame: Day 1]
• Trabecular volumetric mineral density with HR-PQCT [Time frame: Day 1]
• Cortical volumetric mineral density with HR-PQCT [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Chu Saint Etienne — Saint-Etienne

Identifiers

NCT: NCT06541548 · 24CH080 · ANSM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗