Effectiveness of Medical Management of Fibrous Dysplasia of Bone.

Fibrous Dysplasia of Bone Clinical Trial

— Efficience  

Official title:

Effectiveness of Medical Management in the Field of Rare Diseases. The Example of Fibrous Dysplasia of Bone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422833
• Other study ID #: 370
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Fibrous Dysplasia of Bone
• Hyperplasia
• McCune Albright Syndrome

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