OsteoporosisOPGAP01NCT07512453
Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy
An observational study of Osteoporosis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 8,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- patients under the age of 18
- no previous fragility fractures - failure to sign the consent form Exit criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
AOUP Stabilimento di Santa Chiara - UO Endocrinologia
Pisa, PI, 56126
Maurizio Mazzantini, MD, +39, mau.mazzantini@gmail.com
Giammarco De Mattia, MD, +39, demattia.giammarco@hsr.it
About this study
Official title: Retrospective Multicenter 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.
Read the detailed description
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.
- Conditions
- Osteoporosis
- Keywords
- fractures and fragility
- Medical subject headings
- Osteoporosis, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective and primary endpoint
the number of months elapsed between the first fragility (osteoporotic) fracture and the initiation of anti-osteoporotic therapy.
Measured: From enrollment to the end of data records 1 year
Secondary outcomes (1)
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.
Measured: From enrollment to the end of data records 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Mazzantini, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512453
- Sponsor's protocol ID
- OPGAP01_EME_26575
- Acronym
- OPGAP01
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy
- ClinicalTrials.gov ID
- NCT07512453
- Acronym / sponsor ID
- OPGAP01 / OPGAP01_EME_26575
- Conditions
- Osteoporosis
- Keywords
- fractures and fragility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients under the age of 18
- no previous fragility fractures - failure to sign the consent form Exit criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Objective and secondary endpoint
Time frame: From enrollment to the end of data records 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Mazzantini, MD (+39, mau.mazzantini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective and primary endpoint (time frame: From enrollment to the end of data records 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.