Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Study ID
- NCT07512453
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Apr 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 8,000 participants (estimated)
Primary Outcome Measure
Objective and primary endpoint [ Time Frame: From enrollment to the end of data records 1 year ]
Central Contacts
- Maurizio Mazzantini, MD+39
- Giammarco De Mattia, MD+39
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