Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

August 20, 2019 updated by: Centre Hospitalier le Mans

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France
        • Centre Hospitalier Le Mans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who were enrolled in the cohort of the osteoporosis clinic of our hospital between january 2012 and December 2015 following an osteoporotic fracture.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of fractures since the enrollment in the clinic
Time Frame: From the enrollment of patients between january 2012 and december 2015 to the interview date
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of bone mineral density since the enrollment in the clinic
Time Frame: From the enrollment of patients between january 2012 and december 2015 to the interview date
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
Satisfaction with the osteoporosis clinic
Time Frame: From the enrollment of patients between january 2012 and december 2015 to the interview date
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Investigators

  • Principal Investigator: Bénédicte Haettich, MD, Centre Hospitalier du Mans, Rheumatology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

July 20, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-2019-S7/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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