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NCT Number: NCT07512453

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUP Stabilimento di Santa Chiara - UO Endocrinologia

Pisa, PI, 56126, Italy

Location contact

Giammarco De Mattia, MD

CONTACT

[email protected]

+39

Maurizio Mazzantini, MD

CONTACT

[email protected]

+39

Maurizio Mazzantini, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Objective and primary endpoint

    Time frame: 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 outcomes

  1. Objective and secondary endpoint

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giammarco De Mattia, MD

CONTACT

[email protected]

+39

Maurizio Mazzantini, MD

CONTACT

[email protected]

+39

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Acronym: OPGAP01

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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