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NCT07512453Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
8000 (estimated)
First submitted
13 Mar 2026
Start date
1 Apr 2026
Primary completion date
31 Mar 2027
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Diseases
Osteoporosis
NCT number
NCT07512453

What you commit to

  • Study type: Observational
  • Planned participants: 8000
  • From 1 Apr 2026 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • no previous fragility fractures - failure to sign the consent form Exit criteria

Age

  • patients under the age of 18

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AOUP Stabilimento di Santa Chiara - UO Endocrinologia
Coordinator of this site? Confirm its status
PisaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.