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Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994094
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier le Mans

Brief 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.


Condition or disease Intervention/treatment
Osteoporosis Osteoporotic Fractures Other: Telephone interview

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Study Type : Observational
Estimated Enrollment : 147 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
Actual Study Start Date : June 12, 2019
Actual Primary Completion Date : July 20, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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?)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994094


Locations
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France
Centre Hospitalier Le Mans
Le Mans, France
Sponsors and Collaborators
Centre Hospitalier le Mans
Investigators
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Principal Investigator: Bénédicte Haettich, MD Centre Hospitalier du Mans, Rheumatology Department
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Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT03994094    
Other Study ID Numbers: CHM-2019-S7/01
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases