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Completed

NCT Number: NCT04301427

Smallest Significant Value in Osteodensitomery in an Obese Population

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damien JOLLY

Reims, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone Mineral Density

Other

Bone mineral density will be measured twice in all included patients.

Primary outcomes

  1. osteodensitometry in obese population

    Time frame: Day 1

    smallest significant value in osteodensitometry in obese population

Secondary outcomes

  1. osteodensitometry in obese population with BMI between 30 and 35 kg/cm²

    Time frame: Day 1

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

  2. osteodensitometry in obese population with BMI between 35 and 40 kg/cm²

    Time frame: Day 1

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

  3. osteodensitometry in obese population with BMI over 40 kg/cm²

    Time frame: Day 1

    Smallest significant value in osteodensitometry in obese population with BMI over 40 kg/cm²

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: PPVS-ob

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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