Clinical trial NCT06541548: Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporosis Risk
Bone Loss
Keywords: Bone microarchitecture
Bone fragility
osteoporosis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: total volumetric mineral density by HR-pQCT
timeFrame: Day 1
measure: trabecular volumetric mineral density by HR-pQCT
timeFrame: Day 1
measure: Cortical volumetric mineral density by HR-pQCT
timeFrame: Day 1
measure: Describe number of trabeculae by HR-pQCT
timeFrame: Day 1
measure: Trabecular thickness by HR-pQCT
timeFrame: Day 1
measure: cortical thickness (mm) by HR-pQCT
timeFrame: Day 1
measure: trabecular separation by HR-pQCT
timeFrame: Day 1
measure: cortical porosity by HR-pQCT
timeFrame: Day 1
Secondary outcomes:
measure: Total bone mineral content with pQCT
timeFrame: Day 1
measure: Total bone surface with pQCT
timeFrame: Day 1
measure: Total bone density with pQCT
timeFrame: Day 1
measure: Cortical and trabecular density with pQCT
timeFrame: Day 1
measure: bone resistance index with pQCT
timeFrame: Day 1
measure: Bone density by DEXA
timeFrame: Day 1
measure: volumetric mineral density with HR-PQCT
timeFrame: Day 1
measure: Trabecular volumetric mineral density with HR-PQCT
timeFrame: Day 1
measure: Cortical volumetric mineral density with HR-PQCT
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hubert MAROTTE, PhD
role: PRINCIPAL_INVESTIGATOR
References: