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

Starting soon

Conditions studied: Osteoporosis

In brief

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 facts

Study ID

NCT07512453

Run by

Azienda Ospedaliero, Universitaria Pisana

People needed

8000

Starts

2026-04-01

Expected to finish

2029-03-31

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• patients under the age of 18
• no previous fragility fractures - failure to sign the consent form Exit criteria

Where it is running

• AOUP Stabilimento di Santa Chiara - UO Endocrinologia — Pisa, PI, Italy

Full record on ClinicalTrials.gov

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