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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Osteoporosis defined by: History of a documented brittle bone fracture

Bone fragility: Patient with indication for bone densitometry but no history of fracture

Rheumatoid arthritis

Spondyloarthritis

Disqualifiers

No sign written consent

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • HR-pQCT

    Device

    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.

  • pQCT

    Device

    Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.

  • DEXA

    Device

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Patient groupExperimental treatment 3 interventions
Group B: Control groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

total volumetric mineral density by HR-pQCT

Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies

Time frame
Day 1
2

trabecular volumetric mineral density by HR-pQCT

Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.

Time frame
Day 1
3

Cortical volumetric mineral density by HR-pQCT

Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.

Time frame
Day 1
4

Describe number of trabeculae by HR-pQCT

Number of trabeculae (1/mm) as a function of pathologies.

Time frame
Day 1

Secondary outcomes

1

Total bone mineral content with pQCT

Total bone mineral content (mg)

Time frame
Day 1
2

Total bone surface with pQCT

Total bone surface (mm2)

Time frame
Day 1
3

Total bone density with pQCT

Total bone density (mg/mm3)

Time frame
Day 1
4

Cortical and trabecular density with pQCT

Cortical and trabecular density (mg/mm3)

Time frame
Day 1

Other outcomes

Sponsors and contacts

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