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

NCT06541548 | Recruiting

• 2 other identifiers: 24CH080ANSM
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Bone microarchitecture; Bone fragility; osteoporosis

Outcome Measures

Primary Outcomes (8)

• total volumetric mineral density by HR-pQCT

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

  Day 1

• trabecular volumetric mineral density by HR-pQCT

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

  Day 1

• Cortical volumetric mineral density by HR-pQCT

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

  Day 1

• Describe number of trabeculae by HR-pQCT

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

  Day 1

• Trabecular thickness by HR-pQCT

  Describe trabecular thickness (mm) as a function of pathologies.

  Day 1

• cortical thickness (mm) by HR-pQCT

  Describe cortical thickness (mm) as a function of pathologies.

  Day 1

• trabecular separation by HR-pQCT

  Describe trabecular separation (mm) as a function of pathologies.

  Day 1

• cortical porosity by HR-pQCT

  Describe cortical porosity (%) as a function of pathologies.

  Day 1

Secondary Outcomes (9)

• Total bone mineral content with pQCT

  Day 1

• Total bone surface with pQCT

  Day 1

• Total bone density with pQCT

  Day 1

• Cortical and trabecular density with pQCT

  Day 1

• bone resistance index with pQCT

  Day 1

Study Arms (2)

Patient group

EXPERIMENTAL

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

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

Control group

EXPERIMENTAL

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

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

Interventions

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.

Control group; Patient group

pQCT DEVICE

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

Control group; Patient group

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.

Control group; Patient group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hubert MAROTTE, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hubert MAROTTE, PhD

CONTACT

(0)477127643; hubert.marotte@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 7, 2024
• Study Start: February 2, 2026
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)