NCT03402958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

January 10, 2018

Last Update Submit

September 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of prescription of anti-osteoporosis treatments.

    6 months after surgical management for fracture of the upper end of the femur

Secondary Outcomes (1)

  • Factors associated with the sub-prescription.

    Through study completion, an average of 4 months

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Center of Saint-Malo

St-Malo, Britain, 35400, France

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nicolas Belhomme

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

March 28, 2018

Primary Completion

March 28, 2018

Study Completion

March 28, 2018

Last Updated

September 21, 2018

Record last verified: 2018-09

Locations