- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402958
General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly (GEOFRAGE)
September 20, 2018 updated by: Rennes University Hospital
Osteoporosis is a major public health problem.
Its screening and its treatment remain largely insufficient while therapies have demonstrated their effectiveness.
In the event of a severe fracture, the update of the 2016/2017 recommendations, prepared by the Research and Information Group on Osteoporosis and the French Rheumatology Society, concerning osteoporosis recommends a specific treatment with bisphosphonates as first-line treatment, without bone densitometry, regardless of age.
The frequency of prescribing anti-osteoporotic treatment as an outpatient after a fracture of the upper extremity of the femur is very low (2% to 21% according to the studies).
The main factors associated with non-prescription found are co-morbidities (charlson score> 6), dementia, obesity (BMI> 30), chronic alcoholism, male sex, polypharmacy> 4, age.
Conversely, the factors associated with prescribing are recurrent falls (> 2 / year), a history of osteoporotic fracture, an Iso Resource Group> 3, female sex, and corticosteroid therapy.
Study Overview
Status
Completed
Conditions
Detailed Description
- / The collection of patients' characteristics upon admission will be based on the computerized patient file and the paper file: socio-demographic data, co-morbidities, functional status, entry / exit treatments, place of residence, source, balance sheet hospital.
- / Determination with the treating doctor or the pharmacist of the prescriptions of the anti-osteoporotic treatments at 6 months of the hospital care.
- / Research factors associated with the prescription (or non-prescription) of anti-osteoporotic treatments.
Study Type
Observational
Enrollment (Actual)
160
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
-
-
Britain
-
Saint-Malo, Britain, France, 35400
- Hospital Center of Saint-Malo
-
-
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
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated for a fracture of the upper extremity of the femur, included consecutively and retrospectively, during the period of October 2016 - June 2017 at the Saint-Malo Hospital Center
Description
Inclusion Criteria:
- Subjects aged 75 or over (hospitalization criteria in the pathway), admitted to the ortho-geriatric ward of the Saint Malo Hospital Center, treated for a fracture of the upper extremity of the femur.
Exclusion Criteria:
- High-energy fracture, pathological fractures (infection, tumor), persons of legal age subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
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 |
Time Frame |
|---|---|
|
Frequency of prescription of anti-osteoporosis treatments.
Time Frame: 6 months after surgical management for fracture of the upper end of the femur
|
6 months after surgical management for fracture of the upper end of the femur
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors associated with the sub-prescription.
Time Frame: Through study completion, an average of 4 months
|
The main factors associated with non-prescription found are co-morbidities (charlson score> 6), dementia, obesity (BMI> 30), chronic alcoholism, male sex, polypharmacy> 4, age.
Conversely, the factors associated with prescribing are recurrent falls (> 2 / year), a history of osteoporotic fracture, an Iso Resource Group> 3, female sex, and corticosteroid therapy.
|
Through study completion, an average of 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicolas Belhomme, Rennes University Hospital
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)
March 28, 2018
Primary Completion (Actual)
March 28, 2018
Study Completion (Actual)
March 28, 2018
Study Registration Dates
First Submitted
January 10, 2018
First Submitted That Met QC Criteria
January 17, 2018
First Posted (Actual)
January 18, 2018
Study Record Updates
Last Update Posted (Actual)
September 21, 2018
Last Update Submitted That Met QC Criteria
September 20, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC17_309_GEOFRAGE
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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