Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss an… (NCT06541548) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss
France1,000 participantsStarted 2026-02-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
total volumetric mineral density by HR-pQCT
Timeframe: Day 1
2
trabecular volumetric mineral density by HR-pQCT
Timeframe: Day 1
3
Cortical volumetric mineral density by HR-pQCT
Timeframe: Day 1
4
Describe number of trabeculae by HR-pQCT
Timeframe: Day 1
5
Trabecular thickness by HR-pQCT
Timeframe: Day 1
6
cortical thickness (mm) by HR-pQCT
Timeframe: Day 1
7
trabecular separation by HR-pQCT
Timeframe: Day 1
8
cortical porosity by HR-pQCT
Timeframe: Day 1
Trial details
NCT IDNCT06541548
SponsorCentre Hospitalier Universitaire de Saint Etienne