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General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly (GEOFRAGE)

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ClinicalTrials.gov Identifier: NCT03402958
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
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.

Condition or disease
Osteoporosis

Detailed Description:
  1. / 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.
  2. / Determination with the treating doctor or the pharmacist of the prescriptions of the anti-osteoporotic treatments at 6 months of the hospital care.
  3. / Research factors associated with the prescription (or non-prescription) of anti-osteoporotic treatments.

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Frequency of prescription of anti-osteoporosis treatments. [ Time Frame: 6 months after surgical management for fracture of the upper end of the femur ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

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): NCT03402958


Contacts
Contact: Nicolas Belhomme 2 99 28 43 21 ext +33 nicolas.belhomme@chu-rennes.fr
Contact: Mickael Massot m.massotpro@gmail.com

Locations
France
Hospital Center of Saint-Malo Recruiting
Saint-Malo, Britain, France, 35400
Contact: Nicolas Belhomme    2 99 28 43 21 ext +33    nicolas.belhomme@chu-rennes.fr   
Contact: Mickael Massot       m.massotpro@gmail.com   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Nicolas Belhomme Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03402958     History of Changes
Other Study ID Numbers: 35RC17_309_GEOFRAGE
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoporosis
Osteoporotic Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Fractures, Bone
Wounds and Injuries