OsteoporosisDMPOsNCT02532439
Bone Microarchitectural Database Constitution From HR-pQCT Device in Clinical Situation Potentially Associated With Bone Loss
A study testing HR-pQCT, DEXA and pQCT in people with Osteoporosis and Bone Loss, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some factors of fracture occurrence have been highlighted. For example, some diseases or therapy are known to increased risk of bone fracture only in some patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Bone Loss
- What is being tested?
- HR-pQCT, DEXA and pQCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2015to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 patients:
- 1.1.Women or Men taken in charge in Saint-Etienne' Hospital and one of the following pathologies: 1.1-a : Osteoporosis defined as: history of fracture by bone fragility documented 1.1-b : Bone Fragility: Patient with the indication of bone densitometry without a fracture history 1.1-c Articular inflammatory disease: Rheumatoid Arthritis, Spondyloarthritis 1.1-d Endocrine diseases : Primary Hyperparathyroidism, Constitutional Thinness, Anorexia nervosa 1.2. written consent
- For controls:
- 2.1. Episode of acute back pain or radicular pain (lasting for less than a month) with taking corticosteroid less than 1 month 2.2. written consent
Who cannot join
- drugs induced bone loss: 1.1.Anti-aromasine or GnRH agonist for at least 6 months, 1.2. Corticosteroid therapy 1.3. Antiepileptic carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months) 2. fracture due to bone fragility 3. drug with bone effect (bisphosphonate, teriparatide, strontium ranelate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Microarchitectural Database Constitution From High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Device in Clinical Situation Potentially Associated With Bone Loss
Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some factors of fracture occurrence have been highlighted. For example, some diseases or therapy are known to increased risk of bone fracture only in some patients. Accordingly, it is important for clinicians to identify patients at risk for bone fracture. Right now, various tools are available for the clinicians:
- clinical exam,
- bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),
- an algorithm based on interrogation, clinical exam and bone mineral density. However, prediction of bone fracture risk needs to be improved since only 50% of bone fractures can be predicted. DEXA provides information for fracture risk estimation, but it is unable to distinguish cortical part to trabecular part. It also fails to quantify the microstructural properties that influence bone strength. Bone microarchitecture, including the cortical compartment can now be assessed in vivo by the HR-pQCT. This technique allows access to several parameters: on the one hand the volumetric bone mineral density for the whole area measured as well as cortical and trabecular regions, and on the other hand, the thickness and cortical porosity and the number of trabecular, their orientation and distribution.
Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical and trabecular bone microarchitecture.
- Conditions
- Osteoporosis, Bone Loss
- Being tested
- HR-pQCT, DEXA, pQCT
- Keywords
- fracture osteoporosis, bone microarchitecture, Inflammatory joint diseases, Bone fragility, Rheumatoid Arthritis, Spondyloarthritis, Primary Hyperparathyroidism, constitutional thinness, anorexia nervosa
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Osteoporotic Fractures, Arthritis, Rheumatoid, Spondylarthritis, Hyperparathyroidism, Primary, Anorexia Nervosa
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.
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
pQCTDevice
Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Measure bone quality and quantity with HR-pQCT, pQCT and DEXA of patient group Patient group is patient with one of the following pathology : Osteoporosis, Bone Fragility, articular inflammatory disease or Endocrine diseases Receives: Device: HR-pQCT; Device: DEXA; Device: pQCT |
| control group | Experimental | Measure bone quality and quantity with HR-pQCT, pQCT and DEXA of control group. Patient group is patient with episode of acute back pain or radicular pain Receives: Device: HR-pQCT; Device: DEXA; Device: pQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone microarchitecture parameter
Compare between patient group and control group bone microarchitecture parameter.
Different bone microarchitecture parameter is a composite outcome assessed by HR-pQCT : Total volumetric mineral density (mg/ccm HA), Trabecular volumetric mineral density (mg/ccm HA), Cortical volumetric mineral density (mg/ccm HA), Trabecular number ((1/mm), Trabecular thickness (mm), Cortical thickness (mm), Trabecular separation (mm), Cortical porosity (%)
Measured: Day 1
Secondary outcomes (1)
Bone density
Bone density is a composite outcome measured with three devices HR-pQCT, pQCT and DEXA.
Parameters measured with HR-pQCT are : Total volumetric mineral density (mg/ccm HA), Trabecular volumetric mineral density (mg/ccm HA) and Cortical volumetric mineral density (mg/ccm HA).
Parameters measured with pQCT are: total bone mineral content (mg), total bone surface (mm2), total bone density (mg/mm3), cortical and trabecular density (mg/mm3), and the bone resistance index (g2/mm).
Parameter measured by DEXA is Bone Mineral Density (BMD, g/cm2)
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 posted25 Aug 2015 (estimated)
- Study start18 Mar 2015
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Thomas, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532439
- Sponsor's protocol ID
- 1408063
- Other IDs
- 2014-A00771-46
- Acronym
- DMPOs
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2015
- Last updated
- 6 Feb 2024
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Microarchitectural Database Constitution From High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Device in Clinical Situation Potentially Associated With Bone Loss
- ClinicalTrials.gov ID
- NCT02532439
- Acronym / sponsor ID
- DMPOs / 1408063
- Conditions
- Osteoporosis, Bone Loss
- Keywords
- fracture osteoporosis, bone microarchitecture, Inflammatory joint diseases, Bone fragility, Rheumatoid Arthritis, Spondyloarthritis, Primary Hyperparathyroidism, constitutional thinness
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Mar 2015 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 25 Aug 2015 (estimated)
- 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.
Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some factors of fracture occurrence have been highlighted. For example, some diseases or therapy are known to increased risk of bone fracture only in some patients. Accordingly, it is important for clinicians to identify patients at risk for bone fracture. Right now, various tools are available for the clinicians:
- clinical exam,
- bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),
- an algorithm based on interrogation, clinical exam and bone mineral density. However, prediction of bone fracture risk needs to be improved since only 50% of bone fractures can be predicted. DEXA provides information for fracture risk estimation, but it is unable to distinguish cortical part to trabecular part. It also fails to quantify the microstructural properties that influence bone strength. Bone microarchitecture, including the cortical compartment can now be assessed in vivo by the HR-pQCT. This technique allows access to several parameters: on the one hand the volumetric bone mineral density for the whole area measured as well as cortical and trabecular regions, and on the other hand, the thickness and cortical porosity and the number of trabecular, their orientation and distribution.
Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical and trabecular bone microarchitecture.
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: DEXA, Device: pQCTMeasure bone quality and quantity with HR-pQCT, pQCT and DEXA of patient group Patient group is patient with one of the following pathology : Osteoporosis, Bone Fragility, articular inflammatory disease or Endocrine diseases |
| control group | Experimental | Device: HR-pQCT, Device: DEXA, Device: pQCTMeasure bone quality and quantity with HR-pQCT, pQCT and DEXA of control group. Patient group is patient with episode of acute back pain or radicular pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For patients:
- 1.1.Women or Men taken in charge in Saint-Etienne' Hospital and one of the following pathologies: 1.1-a : Osteoporosis defined as: history of fracture by bone fragility documented 1.1-b : Bone Fragility: Patient with the indication of bone densitometry without a fracture history 1.1-c Articular inflammatory disease: Rheumatoid Arthritis, Spondyloarthritis 1.1-d Endocrine diseases : Primary Hyperparathyroidism, Constitutional Thinness, Anorexia nervosa 1.2. written consent
- For controls:
- 2.1. Episode of acute back pain or radicular pain (lasting for less than a month) with taking corticosteroid less than 1 month 2.2. written consent
Key exclusion criteria (1 listed)
- drugs induced bone loss: 1.1.Anti-aromasine or GnRH agonist for at least 6 months, 1.2. Corticosteroid therapy 1.3. Antiepileptic carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months) 2. fracture due to bone fragility 3. drug with bone effect (bisphosphonate, teriparatide, strontium ranelate)
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 | Patient group, control 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 | Patient group, control group |
| pQCTPeripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters. | Device | Patient group, control group |
Primary outcome
Bone microarchitecture parameter
Time frame: Day 1
Compare between patient group and control group bone microarchitecture parameter. Different bone microarchitecture parameter is a composite outcome assessed by HR-pQCT : Total volumetric mineral density (mg/ccm HA), Trabecular volumetric mineral density (mg/ccm HA), Cortical volumetric mineral density (mg/ccm HA), Trabecular number ((1/mm), Trabecular thickness (mm), Cortical thickness (mm), Trabecular separation (mm), Cortical porosity (%)
1 secondary outcome
Bone density
Time frame: day 1
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- 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. This study is not recruiting at the moment.
Thierry Thomas, 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, DEXA and pQCT in people with Osteoporosis 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Feb 2024. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone microarchitecture parameter (time frame: Day 1). 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 6 Feb 2024.