Association Between Dermatoporosis and Fractural Risk (DermatOstéo)

July 16, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild
There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Major patients who are to perform dual X-ray absorptiometry (DMO) densitometry.

Description

Inclusion Criteria:

  • Patient aged between 40 and 90 years old who has to undergo a bone densitometry (BMD) examination by dual X-ray absorptiometry
  • Affiliate or beneficiary of a Social Security scheme
  • Express consent to participate in the study.

Exclusion Criteria:

  • Patient benefiting from a legal protection measure
  • Pregnant or nursing woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare fracture risk between patients with dermatoporosis and those without dermatoporosis
Time Frame: BASELINE
The fracture risk will be calculated using the FRAX score. The presence of dermatoporosis will be assessed by a simple clinical examination of the forearms and defined by the presence of three clinical signs: cutaneous atrophy, Bateman purpura and presence of pseudo-stellar scars.
BASELINE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Thomas SENE, MD PhD, Hôpital Fondation Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TSE_2019_11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Dual X-ray absorptiometry (DMO) densitometry.

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