Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03402958
Other study ID # 35RC17_309_GEOFRAGE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 28, 2018
Est. completion date March 28, 2018

Study information

Verified date September 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 28, 2018
Est. primary completion date March 28, 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hospital Center of Saint-Malo Saint-Malo Britain

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of prescription of anti-osteoporosis treatments. 6 months after surgical management for fracture of the upper end of the femur
Secondary Factors associated with the sub-prescription. 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Completed NCT03822078 - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women Phase 1
Recruiting NCT05845021 - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Completed NCT04736693 - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting NCT06431867 - Primary Care Management of Osteoporosis in Older Women
Completed NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A
Completed NCT01401556 - C-STOP Fracture Trial N/A