Smallest Significant Value in Osteodensitomery in an Obese Population

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Bone mineral density

• Registration Number: NCT04301427
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obese patient	Bone mineral density	-

Primary Outcome Measures

Name	Time	Method
osteodensitometry in obese population	Day 1	smallest significant value in osteodensitometry in obese population

Secondary Outcome Measures

Name	Time	Method
osteodensitometry in obese population with BMI over 40 kg/cm²	Day 1	Smallest significant value in osteodensitometry in obese population with BMI over 40 kg/cm²
osteodensitometry in obese population with BMI between 35 and 40 kg/cm²	Day 1	smallest significant value in osteodensitometry in obese population with BMI between 35 et 40 kg/cm²
osteodensitometry in obese population with BMI between 30 and 35 kg/cm²	Day 1	smallest significant value in osteodensitometry in obese population with BMI between 30 et 35 kg/cm²

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France