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

Centre Hospitalier Universitaire de Saint Etienne

Status: Not yet enrolling

Conditions: Osteoporosis Risk; Bone Loss

Treatments: Device: DEXA; Device: pQCT; Device: HR-pQCT

Study type: Interventional

Funder types: Other

Identifiers

NCT06541548

ANSM (Other Identifier)

24CH080

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Patient group

Experimental group

Description:

Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis.

Treatment:

Device: HR-pQCT

Device: DEXA

Device: pQCT

Control group

Experimental group

Description:

Describe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis.

Treatment:

Device: HR-pQCT

Device: DEXA

Device: pQCT