DermatOstéo: Association Between Dermatoporosis and Fractural Risk
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT03998228
Collaborator
(none)
100
1
4
24.7
Study Details
Study Description
Brief Summary
There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Association Between Dermatoporosis and Fractural Risk
Actual Study Start Date
:
Oct 1, 2020
Actual Primary Completion Date
:
Feb 1, 2021
Actual Study Completion Date
:
Feb 1, 2021
Outcome Measures
Primary Outcome Measures
- compare fracture risk between patients with dermatoporosis and those without dermatoporosis [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Fondation Adolphe de Rothschild | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
- Principal Investigator: Thomas SENE, MD PhD, Hôpital Fondation Adolphe de Rothschild
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT03998228
Other Study ID Numbers:
- TSE_2019_11
First Posted:
Jun 26, 2019
Last Update Posted:
Jul 19, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No