Osteoporosis
Conditions
Keywords
fractures and fragility
Brief summary
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.
Detailed description
Italian real-life study in patients with osteoporosis and fragility fractures to assess the extent and impact of delays in the administration of anti-fracture therapy.
Interventions
None listed
Sponsors
Azienda Ospedaliero, Universitaria Pisana
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* patients under the age of 18 * no previous fragility fractures - failure to sign the consent form Exit criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective and primary endpoint | From enrollment to the end of data records 1 year | the number of months elapsed between the first fragility (osteoporotic) fracture and the initiation of anti-osteoporotic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective and secondary endpoint | From enrollment to the end of data records 1 year | the incidence of new fragility (osteoporotic) fractures based on the time elapsed between the first fragility fracture and the initiation of anti-osteoporotic therapy. |
Countries
Italy
Contacts
CONTACTMaurizio Mazzantini, MD
CONTACTGiammarco De Mattia, MD
Outcome results
None listed