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

Primary Purpose

Osteoporosis, Bone Loss

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HR-pQCT
DEXA
pQCT
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoporosis focused on measuring fracture osteoporosis, bone microarchitecture, Inflammatory joint diseases, Bone fragility, Rheumatoid Arthritis, Spondyloarthritis, Primary Hyperparathyroidism, constitutional thinness, anorexia nervosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Chu Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient group

control group

Arm 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

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

Outcomes

Primary Outcome Measures

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 (%)

Secondary Outcome Measures

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)

Full Information

First Posted
August 21, 2015
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02532439
Brief Title
Bone Microarchitectural Database Constitution From HR-pQCT Device in Clinical Situation Potentially Associated With Bone Loss
Acronym
DMPOs
Official Title
Bone Microarchitectural Database Constitution From High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Device in Clinical Situation Potentially Associated With Bone Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2015 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Bone Loss
Keywords
fracture osteoporosis, bone microarchitecture, Inflammatory joint diseases, Bone fragility, Rheumatoid Arthritis, Spondyloarthritis, Primary Hyperparathyroidism, constitutional thinness, anorexia nervosa

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Experimental
Arm 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
Arm Title
control group
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
HR-pQCT
Intervention Description
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
Intervention Name(s)
DEXA
Intervention Description
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
Intervention Name(s)
pQCT
Intervention Description
Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.
Primary Outcome Measure Information:
Title
Bone microarchitecture parameter
Description
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 (%)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Bone density
Description
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)
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert Marotte, PhD
Phone
(0)477127643
Email
hubert.marotte@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Thomas, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert Marotte, PhD
Phone
(0)477127643
Ext
+33
Email
hubert.marotte@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Thierry Thomas, PhD
First Name & Middle Initial & Last Name & Degree
Hubert Marotte, PhD
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Lafage-Proust, PhD
First Name & Middle Initial & Last Name & Degree
Adamah Amouzougan, MD
First Name & Middle Initial & Last Name & Degree
Béatrice Pallot-Prades, MD
First Name & Middle Initial & Last Name & Degree
Bogdan Galusca, MD
First Name & Middle Initial & Last Name & Degree
Natacha Germain, PhD
First Name & Middle Initial & Last Name & Degree
Karima BOUSSOUALIM, MD
First Name & Middle Initial & Last Name & Degree
Jean-Philippe CAMDESSANCHE, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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