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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05422833
Other study ID # 370
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1996
Est. completion date December 2019

Study information

Verified date June 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of our study was to assess the effectiveness of our reference center since its constitution. In a retrospective cohort study, we compared the activity of our center, including the time elapsed between diagnosis and access to the center and the diagnostic delay of patients with fibrous dysplasia between two periods, 1996-2006 (before certification of our center) and 2007-2019 (after certification of our center).


Recruitment information / eligibility

Status Completed
Enrollment 528
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: We have included children and adults with FD/MAS who visited at least once in our center (outpatient and hospitalized patients). The diagnosis was established by an expert of the center, based on clinical, biological, imaging and/or histological arguments Exclusion Criteria: The absence of detectable bone lesion

Study Design


Intervention

Other:
Evaluation and analysis of clinical data
Evaluation and analysis of clinical data (baseline demographic features (sex, age at diagnosis, age at first symptoms, age at first visit), initial presenting symptoms, affected bone sites (monostotic FD or polyostotic FD), renal phosphate wasting, MAS, Mazabraud syndrome, endocrine disease, fractures, bone specific treatment especially bisphosphonate and surgery, pain and disease's severity.

Locations

Country Name City State
France rheumatology department, hopital Edouard Herriot Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary to compare time elapsed between first symptomes or discovery of bone lesions and the diagnosis of FD The main objective was to compare time elapsed between first symptomes or discovery of bone lesions and the diagnosis of FD, over 2 periods of time: 1996-2006 (before certification) and 2007-2019 (after certification). 1996-2019
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Active, not recruiting NCT05509595 - Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia Phase 2