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Bone Microarchitectural Database Constitution From HR-pQCT Device in Clinical Situation Potentially Associated With Bone Loss (DMPOs)

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ClinicalTrials.gov Identifier: NCT02532439
Recruitment Status : Recruiting
First Posted : August 25, 2015
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Osteoporosis Bone Loss Device: HR-pQCT Device: DEXA Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bone Microarchitectural Database Constitution From High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Device in Clinical Situation Potentially Associated With Bone Loss
Actual Study Start Date : March 18, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient group
Measure bone quality and quantity with HR-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
Device: HR-pQCT

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.


Device: DEXA
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

Experimental: control group
Measure bone quality and quantity with HR-pQCT and DEXA of control group. Patient group is patient with episode of acute back pain or radicular pain
Device: HR-pQCT

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.


Device: DEXA
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 Outcome Measures :
  1. 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 (%)



Secondary Outcome Measures :
  1. Bone density [ Time Frame: day 1 ]

    Bone density is a composite outcome measured with two devices HR-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).

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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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

  2. 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

Exclusion Criteria:

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532439


Contacts
Contact: Hubert Marotte, PhD (0)477127643 hubert.marotte@chu-st-etienne.fr

Locations
France
Chu Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Hubert Marotte, PhD    (0)477127643 ext +33    hubert.marotte@chu-st-etienne.fr   
Principal Investigator: Thierry Thomas, PhD         
Sub-Investigator: Hubert Marotte, PhD         
Sub-Investigator: Marie-Hélène Lafage-Proust, PhD         
Sub-Investigator: Adamah Amouzougan, MD         
Sub-Investigator: Béatrice Pallot-Prades, MD         
Sub-Investigator: Philippe Collet, MD         
Sub-Investigator: Elodie Constant, MD         
Sub-Investigator: Bogdan Galusca, MD         
Sub-Investigator: Natacha Germain, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Thierry Thomas, PhD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02532439     History of Changes
Other Study ID Numbers: 1408063
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
fracture osteoporosis
bone microarchitecture
Inflammatory joint diseases
Bone fragility
Rheumatoid Arthritis
Spondyloarthritis
Primary Hyperparathyroidism
constitutional thinness
anorexia nervosa

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases