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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Osteoporosis; Bone Loss

Treatments: Device: pQCT; Device: DEXA; Device: HR-pQCT

Study type: Interventional

Funder types: Other

Identifiers

NCT02532439

1408063

2014-A00771-46 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

Patient group

Experimental group

Description:

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

Treatment:

Device: pQCT

Device: DEXA

Device: HR-pQCT

control group

Experimental group

Description:

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

Treatment:

Device: pQCT

Device: DEXA

Device: HR-pQCT