Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy

ConditionOsteoporosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero, Universitaria Pisana

About this trial

Osteoporosis (OP) and fragility fractures are a significant problem that leads to morbidity, mortality, and high costs for the National Health System. The treatment of fragility fractures includes numerous anti-resorptive and anabolic drugs, and its goal is the secondary prevention of new fractures. It is well known that the risk of a new fracture following a fracture event is highest in the months immediately following the first fracture. However, recent data clearly show a dramatic global delay in the administration of anti-osteoporotic therapy following a fragility fracture. It has been estimated that in Italy, 71% of patients with fragility fractures eligible for anti-fracture treatment did not receive timely treatment (a problem defined as a "treatment gap"), and that in 2034, the incidence of new fragility fractures will increase compared to 2019 \[1\]. However, there is a lack of real-life Italian data on the extent of the treatment gap in osteoporotic patients with fragility fractures and its impact in terms of the incidence of subsequent fragility fractures: this study therefore aims to fill this gap by collecting data from a large population of patients attending several centers throughout the country.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients of both sexes;

patients with osteoporosis and/or previous fragility fractures (fragility fractures are defined as those that occur spontaneously, i.e., not resulting from trauma, even of low intensity, or those caused by a fall from standing height.

willingness to sign the consent form

Disqualifiers

patients under the age of 18

no previous fragility fractures - failure to sign the consent form Exit criteria

Trial population

Consecutive adults affected by osteoporosis and fragility fractures attending regular outpatient visits at participating centers. After submitting written informed consent for enrollment in the study, the information necessary for the study will be collected. The information that will be collected is that contained in the medical records, acquired in normal clinical practice for the management of this type of patient.

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Objective and primary endpoint

the number of months elapsed between the first fragility (osteoporotic) fracture and the initiation of anti-osteoporotic therapy.

Time frame
From enrollment to the end of data records 1 year

Secondary outcomes

1

Objective and secondary endpoint

the incidence of new fragility (osteoporotic) fractures based on the time elapsed between the first fragility fracture and the initiation of anti-osteoporotic therapy.

Time frame
From enrollment to the end of data records 1 year

Other outcomes

Sponsors and contacts

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