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

NCT ID: NCT02532439

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-18
• Study Completion Date: 2019-03-18

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.

Conditions

Osteoporosis; Bone Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient group

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

Group Type: EXPERIMENTAL

HR-pQCT

Intervention Type: DEVICE

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.

DEXA

Intervention Type: DEVICE

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

pQCT

Intervention Type: DEVICE

Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.

control group

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

Group Type: EXPERIMENTAL

HR-pQCT

Intervention Type: DEVICE

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.

DEXA

Intervention Type: DEVICE

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

pQCT

Intervention Type: DEVICE

Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

pQCT

Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2014-A00771-46

Identifier Type: OTHER

Identifier Source: secondary_id

1408063

Identifier Type: -

Identifier Source: org_study_id