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 volunteersQualifiers
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
Case-only
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Objective and primary endpoint
the number of months elapsed between the first fragility (osteoporotic) fracture and the initiation of anti-osteoporotic therapy.
Secondary outcomes
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: