Association Between Dermatoporosis and Fractural Risk

NCT03998228 | Completed

• 1 other identifier: TSE_2019_11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.

Conditions

Dermatoporosis

Outcome Measures

Primary Outcomes (1)

• compare fracture risk between patients with dermatoporosis and those without dermatoporosis

  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

Interventions

Dual X-ray absorptiometry (DMO) densitometry. DIAGNOSTIC_TEST

Simple clinical examination with forearm inspection and palpation; * Radiological examination of BMD; * Calculation of the FRAX® score; * Fact sheet on patients with dermatoporosis, proposal of a topical treatment (cosmetic cream) and completion of the questionnaire specific to dermatoporosis

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas SENE, MD PhD

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: October 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 19, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)