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Smallest Significant Value in Osteodensitomery in an Obese Population (PPVS-ob)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone mineral density
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring Bone density, Osteoporosis, Osteopenia, Obesity, OSteodensitometry

Eligibility Criteria

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

Inclusion criteria :

  • Major patients
  • Patients referred to the CHU of Reims to make an osteodensitometric evaluation of their bone mineral density
  • BMI > 30 kg/cm²
  • Patient affiliated to a health insurance plan
  • Patients who have signed informed consent

Exclusion criteria :

  • Minor patients
  • Pregnant women
  • Patients protected by the law

Sites / Locations

  • Damien JOLLY

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Obese patient

Arm Description

Outcomes

Primary Outcome Measures

osteodensitometry in obese population
smallest significant value in osteodensitometry in obese population

Secondary Outcome Measures

osteodensitometry in obese population with BMI between 30 and 35 kg/cm²
smallest significant value in osteodensitometry in obese population with BMI between 30 et 35 kg/cm²
osteodensitometry in obese population with BMI between 35 and 40 kg/cm²
smallest significant value in osteodensitometry in obese population with BMI between 35 et 40 kg/cm²
osteodensitometry in obese population with BMI over 40 kg/cm²
Smallest significant value in osteodensitometry in obese population with BMI over 40 kg/cm²

Full Information

First Posted
March 6, 2020
Last Updated
September 16, 2020
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT04301427
Brief Title
Smallest Significant Value in Osteodensitomery in an Obese Population
Acronym
PPVS-ob
Official Title
Smallest Significant Value in Osteodensitomery in an Obese Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI. Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined. Our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.
Detailed Description
The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. There will be at least 120 patient included. The study population will be divided in 3 groups according to their BMI : the first group has a BMI between 30 and 35 kg/cm² ; the second group has a BMI between 35 et 40 kg/cm² ; and the third group has a BMI over 40 kg/cm². Patients will be referred by their doctors (rheumatologist and others) to evaluate their bone mineral density in osteodensitometry at CHU of Reims. Patients will be informed of the aim of the study by the prescriptor of the osteodensitometry. The osteodensitometry will be executed by a nurse. Patients will have to complete a questionnaire about their medical history and their medications. Bone mineral density will be measured twice in osteodensitometry, at the lumbar spine, the hip and the femur. This exam lasts approximately 40 minutes. Then the smallest significant value will be determined by comparing each measure for every patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Bone density, Osteoporosis, Osteopenia, Obesity, OSteodensitometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese patient
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Bone mineral density
Intervention Description
Bone mineral density will be measured twice in all included patients.
Primary Outcome Measure Information:
Title
osteodensitometry in obese population
Description
smallest significant value in osteodensitometry in obese population
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
osteodensitometry in obese population with BMI between 30 and 35 kg/cm²
Description
smallest significant value in osteodensitometry in obese population with BMI between 30 et 35 kg/cm²
Time Frame
Day 1
Title
osteodensitometry in obese population with BMI between 35 and 40 kg/cm²
Description
smallest significant value in osteodensitometry in obese population with BMI between 35 et 40 kg/cm²
Time Frame
Day 1
Title
osteodensitometry in obese population with BMI over 40 kg/cm²
Description
Smallest significant value in osteodensitometry in obese population with BMI over 40 kg/cm²
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Major patients Patients referred to the CHU of Reims to make an osteodensitometric evaluation of their bone mineral density BMI > 30 kg/cm² Patient affiliated to a health insurance plan Patients who have signed informed consent Exclusion criteria : Minor patients Pregnant women Patients protected by the law
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France

12. IPD Sharing Statement

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Smallest Significant Value in Osteodensitomery in an Obese Population

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