NCT04301427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 21, 2026

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

March 6, 2020

Last Update Submit

January 19, 2026

Conditions

Obesity

Keywords

Bone densityOsteoporosisOsteopeniaObesityOSteodensitometry

Outcome Measures

Primary Outcomes (1)

  • osteodensitometry in obese population

    smallest significant value in osteodensitometry in obese population

    Day 1

Secondary Outcomes (3)

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

    Day 1

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

    Day 1

  • osteodensitometry in obese population with BMI over 40 kg/cm²

    Day 1

Study Arms (1)

Obese patient

OTHER
Other: Bone mineral density

Interventions

Bone mineral densityOTHER

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

Obese patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • Dorilleau C, Kanagaratnam L, Charlot I, Hittinger A, Bertin E, Salmon JH, Geoffroy M. "The least significant change on bone mineral density scan increased in patients with higher degrees of obesity". Aging Clin Exp Res. 2024 Apr 23;36(1):98. doi: 10.1007/s40520-024-02736-4.

    PMID: 38652346BACKGROUND

MeSH Terms

Conditions

ObesityOsteoporosisBone Diseases, Metabolic

Interventions

Bone Density

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

November 15, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 21, 2026

Record last verified: 2020-09

Locations

FR(1)