NCT02965742

Brief Summary

The main objectives of this study are:

  • to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.
  • to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

3.4 years

First QC Date

November 10, 2016

Last Update Submit

March 13, 2019

Conditions

Osteodensitometry

Keywords

DXADMSDMS ImagingSTRATOSHorizon AQDR4500A

Outcome Measures

Primary Outcomes (1)

  • Lin concordance coefficient

    In order to get a first idea of the adequacy of the two techniques measurements of the two bone densitometers, a calculation of intraclass correlation coefficients will be done. To supplement this data, a correlation study between the two techniques will be performed. For this we will use the Bland-Altman technique and a study of LIN concordance correlation coefficient

    Day 0

Study Arms (2)

The study population: first 25 patients

EXPERIMENTAL

The study population consists of patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"

Device: StratosDevice: "Hologic QDR 4500A"Device: "Hologic HORIZON A"

The study population: last 25 patients

EXPERIMENTAL

The study population consists of sportsmen patients referred to the Nuclear Medicine and Medical Biophysics Department of the Montpellier University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body and sub-regions exams using the "Stratos" Intervention: Whole body and sub-regions exams using the "Hologic QDR 4500A" Intervention: Whole body and sub-regions exams using the "Hologic HORIZON A"

Device: StratosDevice: "Hologic QDR 4500A"Device: "Hologic HORIZON A"

Interventions

StratosDEVICE

A machine made by DMS group.

The study population: first 25 patientsThe study population: last 25 patients
"Hologic QDR 4500A"DEVICE

A machine made by Hologic inc.

The study population: first 25 patientsThe study population: last 25 patients
"Hologic HORIZON A"DEVICE

A machine made by Hologic inc.

The study population: first 25 patientsThe study population: last 25 patients

Eligibility Criteria

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

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is referred by a doctor for the performance of an osteodensitometry examination or sportsmen coming through a protocol where the nuclear medicine department is the investigator center

You may not qualify if:

  • The patient is pregnant or nursing
  • The patient is unable to sign or refuse to sign the informed consent
  • The patient has a coronary stent or metal sutures in the heart
  • The patient has any type of metal objects in the body such as an artificial joint, a pin or a metal plate
  • The patient has a pacemaker or defibrillator
  • Patient weighing more than 200 kg or more than 2 meters high by 65 centimeters wide
  • The patient is using an insulin pump or with insulin-necked
  • The patient has undergone X-ray examination using a contrast medium such as barium in the previous seven days visit,
  • Patient who underwent an examination using x rays in the 15 days preceding the visit
  • Patient suffering from generalized edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, Hérault, 34295, France

RECRUITING

Study Officials

  • Denis MARIANO-GOULART, Phd.Medecine

    Nuclear department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent MAIMOUN, Phd.

CONTACT

0467338464l-maimoun@chu-montpellier.fr

Sana EL OUAZGHARI, Bsc.

CONTACT

0466271059selouazghari@dms-imaging.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 17, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

FR(1)