Osteoporosis RiskMICROSNCT06541548
Comparison of Bone Microarchitecture Analysed by HRpQCT and pQCT in Pathologies With Bone Loss and/or Muscle Loss
A study testing HR-pQCT, pQCT and DEXA in people with Osteoporosis Risk and Bone Loss, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis Risk, Bone Loss
- What is being tested?
- HR-pQCT, pQCT and DEXA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Saint Etienne
Saint-Etienne, 42055
Hubert MAROTTE, PhD, (0)477127649 ext. +33, hubert.marotte@chu-st-etienne.fr
Florence Rancon, (0)477829458 ext. +33, florence.rancon@chu-st-etienne.fr
About this study
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
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
- Being tested
- HR-pQCT, pQCT, DEXA
- Keywords
- Bone microarchitecture, Bone fragility, osteoporosis
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
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.
pQCTDevice
Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.
DEXADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Describe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis. Receives: 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. Receives: Device: HR-pQCT; Device: pQCT; Device: DEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
total volumetric mineral density by HR-pQCT
Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies
Measured: Day 1
trabecular volumetric mineral density by HR-pQCT
Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.
Measured: Day 1
Cortical volumetric mineral density by HR-pQCT
Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.
Measured: Day 1
Describe number of trabeculae by HR-pQCT
Number of trabeculae (1/mm) as a function of pathologies.
Measured: Day 1
Trabecular thickness by HR-pQCT
Describe trabecular thickness (mm) as a function of pathologies.
Measured: Day 1
cortical thickness (mm) by HR-pQCT
Describe cortical thickness (mm) as a function of pathologies.
Measured: Day 1
trabecular separation by HR-pQCT
Describe trabecular separation (mm) as a function of pathologies.
Measured: Day 1
cortical porosity by HR-pQCT
Describe cortical porosity (%) as a function of pathologies.
Measured: Day 1
Secondary outcomes (9)
Total bone mineral content with pQCT
Total bone mineral content (mg)
Measured: Day 1
Total bone surface with pQCT
Total bone surface (mm2)
Measured: Day 1
Total bone density with pQCT
Total bone density (mg/mm3)
Measured: Day 1
Cortical and trabecular density with pQCT
Cortical and trabecular density (mg/mm3)
Measured: Day 1
bone resistance index with pQCT
bone resistance index (g2/mm)
Measured: Day 1
Bone density by DEXA
Parameter measured by DEXA is Bone Mineral Density (BMD, g/cm2).
Measured: Day 1
volumetric mineral density with HR-PQCT
Total volumetric mineral density (mg/ccm HA)
Measured: Day 1
Trabecular volumetric mineral density with HR-PQCT
Trabecular volumetric mineral density (mg/ccm HA)
Measured: Day 1
Cortical volumetric mineral density with HR-PQCT
Cortical volumetric mineral density (mg/ccm HA).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start2 Feb 2026
- Primary completionMay 2035 (estimated)
- Study completionMay 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis RiskStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert MAROTTE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541548
- Sponsor's protocol ID
- 24CH080
- Other IDs
- ANSM
- Acronym
- MICROS
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06541548
- Acronym / sponsor ID
- MICROS / 24CH080
- Conditions
- Osteoporosis Risk, Bone Loss
- Keywords
- Bone microarchitecture, Bone fragility, osteoporosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- May 2035 (estimated)
- Study completion
- May 2035 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Device: HR-pQCT, Device: pQCT, Device: DEXADescribe bone quality and quantity with HR-pQCT, pQCT and DEXA in the group of patients at risk of osteoporosis. |
| Control group | Experimental | Device: HR-pQCT, Device: pQCT, Device: DEXADescribe the quality and quantity of bones with HR-pQCT, pQCT and DEXA in the group of patients not at risk of osteoporosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Chronic kidney disease
Key exclusion criteria (8 listed)
- No sign written consent
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-pQCTXtreme 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. | Device | Control group, Patient group |
| pQCTPeripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters. | Device | Control group, Patient group |
| DEXAThe 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. | Device | Control group, Patient group |
Primary outcome
total volumetric mineral density by HR-pQCT
Time frame: Day 1
Describe total volumetric mineral density (mg/ccm HA) as a function of pathologies
trabecular volumetric mineral density by HR-pQCT
Time frame: Day 1
Describe trabecular volumetric mineral density (mg/ccm HA) as a function of pathologies.
Cortical volumetric mineral density by HR-pQCT
Time frame: Day 1
Describe cortical volumetric mineral density (mg/ccm HA) as a function of pathologies.
Describe number of trabeculae by HR-pQCT
Time frame: Day 1
Number of trabeculae (1/mm) as a function of pathologies.
Trabecular thickness by HR-pQCT
Time frame: Day 1
Describe trabecular thickness (mm) as a function of pathologies.
cortical thickness (mm) by HR-pQCT
Time frame: Day 1
Describe cortical thickness (mm) as a function of pathologies.
trabecular separation by HR-pQCT
Time frame: Day 1
Describe trabecular separation (mm) as a function of pathologies.
cortical porosity by HR-pQCT
Time frame: Day 1
Describe cortical porosity (%) as a function of pathologies.
9 secondary outcomes
Total bone mineral content with pQCT
Time frame: Day 1
Total bone surface with pQCT
Time frame: Day 1
Total bone density with pQCT
Time frame: Day 1
Cortical and trabecular density with pQCT
Time frame: Day 1
bone resistance index with pQCT
Time frame: Day 1
Bone density by DEXA
Time frame: Day 1
volumetric mineral density with HR-PQCT
Time frame: Day 1
Trabecular volumetric mineral density with HR-PQCT
Time frame: Day 1
Cortical volumetric mineral density with HR-PQCT
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hubert MAROTTE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT, pQCT and DEXA in people with Osteoporosis Risk and Bone Loss, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hubert MAROTTE, PhD ((0)477127643 ext. +33, hubert.marotte@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total volumetric mineral density by HR-pQCT (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.