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

NCT ID: NCT06541548

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2035-05-31

Brief Summary

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.

Conditions

Osteoporosis Risk; Bone Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient group

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

Group Type: EXPERIMENTAL

HR-pQCT

Intervention Type: 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

Intervention Type: DEVICE

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

DEXA

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

HR-pQCT

Intervention Type: 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

Intervention Type: DEVICE

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

DEXA

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

pQCT

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

Intervention Type: 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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert MAROTTE, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint Etienne

Saint-Etienne, , France

Countries

France

Central Contacts

Hubert MAROTTE, PhD

Role: CONTACT

hubert.marotte@chu-st-etienne.fr

(0)477127643 ext. +33

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

24CH080

Identifier Type: -

Identifier Source: org_study_id