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NCT Number: NCT06541548

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

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.

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Key information

Conditions

Osteoporosis Risk Bone Diseases Bone Diseases, Metabolic Bone Loss Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Adamah AMOUZOUGAN, MD

SUB_INVESTIGATOR

Florence Rancon

CONTACT

[email protected]

(0)477829458 ext. +33

Hubert MAROTTE, PhD

CONTACT

[email protected]

(0)477127649 ext. +33

Hubert MAROTTE, PhD

PRINCIPAL_INVESTIGATOR

Tierry THOMAS, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. total volumetric mineral density by HR-pQCT

    Time frame: Day 1

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

  2. trabecular volumetric mineral density by HR-pQCT

    Time frame: Day 1

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

  3. Cortical volumetric mineral density by HR-pQCT

    Time frame: Day 1

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

  4. Describe number of trabeculae by HR-pQCT

    Time frame: Day 1

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

  5. Trabecular thickness by HR-pQCT

    Time frame: Day 1

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

  6. cortical thickness (mm) by HR-pQCT

    Time frame: Day 1

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

  7. trabecular separation by HR-pQCT

    Time frame: Day 1

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

  8. cortical porosity by HR-pQCT

    Time frame: Day 1

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

Secondary outcomes

  1. Total bone mineral content with pQCT

    Time frame: Day 1

    Total bone mineral content (mg)

  2. Total bone surface with pQCT

    Time frame: Day 1

    Total bone surface (mm2)

  3. Total bone density with pQCT

    Time frame: Day 1

    Total bone density (mg/mm3)

  4. Cortical and trabecular density with pQCT

    Time frame: Day 1

    Cortical and trabecular density (mg/mm3)

  5. bone resistance index with pQCT

    Time frame: Day 1

    bone resistance index (g2/mm)

  6. Bone density by DEXA

    Time frame: Day 1

    Parameter measured by DEXA is Bone Mineral Density (BMD, g/cm2).

  7. volumetric mineral density with HR-PQCT

    Time frame: Day 1

    Total volumetric mineral density (mg/ccm HA)

  8. Trabecular volumetric mineral density with HR-PQCT

    Time frame: Day 1

    Trabecular volumetric mineral density (mg/ccm HA)

  9. Cortical volumetric mineral density with HR-PQCT

    Time frame: Day 1

    Cortical volumetric mineral density (mg/ccm HA).

Study contacts

Contact information is provided by the study sponsor or research team.

Hubert MAROTTE, PhD

CONTACT

[email protected]

(0)477127643 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: MICROS

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Aug 7, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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