Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Osteoporosis Clinical Trial

Official title:

Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03994094
• Other study ID #: CHM-2019-S7/01
• Status: Enrolling by invitation
• Start date: June 12, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: June 2019
• Source: Centre Hospitalier le Mans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.

The effectiveness specialized osteoporosis clinics is the subject of numerous publications.

It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 147
• Est. completion date: September 1, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015

• Acceptation of the telephone interview

Exclusion Criteria:

• Age < 18 years

• No social security coverage

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporotic Fractures

Intervention

Other:
• Telephone interview
Structured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fractures since the enrollment in the clinic	Number of incident fractures suffered by the patient since their enrollment in the osteoporosis clinic.	From the enrollment of patients between january 2012 and december 2015 to the interview date
Secondary	Evolution of bone mineral density since the enrollment in the clinic	Evolution of the bone mineral density since their enrollment in the osteoporosis clinic	From the enrollment of patients between january 2012 and december 2015 to the interview date
Secondary	Satisfaction with the osteoporosis clinic	Level of satisfaction measured with a four level Lickert scale ( Very satisfied ? Satisfied? Unsatisfied? Dissatisfied?)	From the enrollment of patients between january 2012 and december 2015 to the interview date