An observational study in Osteoporosis, sponsored by Azienda Ospedaliero, Universitaria Pisana. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Observational
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.
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.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 8,000 is above the median of 160 across 455 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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
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
Plan to share: Yes
Supporting information: Clinical study report
Time frame: at the and of the study, approximately 3 years
Access criteria: scientific community
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero, Universitaria Pisana