Osteoporosis RiskRIFRANCT06448325
Fragility Re-fractures Prediction Score
An observational study of Osteoporosis Risk, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure. Osteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporosis Risk
- What is being tested?
- Hip arthroplasty
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 or more, of all sexes.
Who may be able to join
- People who underwent total or partial hip replacement (ICD 9 CM 81.51, 81.52) in five years (2013-2017) at the hospital for a compound fracture of the hip (ICD 9 CM 820, 820.01-820.09).
Who cannot join
- People undergoing the same intervention for other reasons (e.g. pathological fracture, ICD 9 CM 733.14).
- ICD 9 CM stands for International Classification of Disease, 9th Revision, Clinical Modification.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Italia, 20157
Susan Bernareggi, 0039 0226432911, segreteria.comitatoetico@hsr.it
Federico Pennestrì, PhD
About this study
Official title: RIFRA - Re-fracture Risk Prediction in Patients With Fragility Fracture: Score Development and Validation
Fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure.
Osteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. Even after that, further fractures do occurr, as osteoporosis is often untreated. Several programs have been introduced worldwide to prevent secondary fractures among the population at risk (e.g., International Osteoporosis Foundation's Capture the Fracture), and several risk factors are being investigated to generate a predictive score. However, accurate validation is needed to make these scores reliable.
In this retrospective observational study, we aim to validate a predictive score trained on a population of elderly patients with a cohort of patients who underwent hip fracture surgery in a high-volume orthopedic center in the Region of Lombardy.
- Conditions
- Osteoporosis Risk
- Being tested
- Hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroplastyOther
Surgical treatment of the hip after osteoporosis fracture. The focus of the study is the prediction of further fractures (and therefore further surgical procedures) after the first one.
What is being measured
The primary outcome is the main question the study is designed to answer.
Age, sex, disease name and body mass index (weight in kg and height in m will be combined to report BMI in kg/m^2)
Patient characteristics and comorbidities associated with a fragility fracture of the hip
Measured: Baseline: the outcomes are assessed before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start28 May 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis RiskStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448325
- Sponsor's protocol ID
- RIFRA
- Acronym
- RIFRA
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIFRA - Re-fracture Risk Prediction in Patients With Fragility Fracture: Score Development and Validation
- ClinicalTrials.gov ID
- NCT06448325
- Acronym / sponsor ID
- RIFRA / RIFRA
- Conditions
- Osteoporosis Risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 7 Jun 2024 (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.
Fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure.
Osteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. Even after that, further fractures do occurr, as osteoporosis is often untreated. Several programs have been introduced worldwide to prevent secondary fractures among the population at risk (e.g., International Osteoporosis Foundation's Capture the Fracture), and several risk factors are being investigated to generate a predictive score. However, accurate validation is needed to make these scores reliable.
In this retrospective observational study, we aim to validate a predictive score trained on a population of elderly patients with a cohort of patients who underwent hip fracture surgery in a high-volume orthopedic center in the Region of Lombardy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 or more, of all sexes.
Key inclusion criteria (1 listed)
- People who underwent total or partial hip replacement (ICD 9 CM 81.51, 81.52) in five years (2013-2017) at the hospital for a compound fracture of the hip (ICD 9 CM 820, 820.01-820.09).
Key exclusion criteria (2 listed)
- People undergoing the same intervention for other reasons (e.g. pathological fracture, ICD 9 CM 733.14).
- ICD 9 CM stands for International Classification of Disease, 9th Revision, Clinical Modification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip arthroplastySurgical treatment of the hip after osteoporosis fracture. The focus of the study is the prediction of further fractures (and therefore further surgical procedures) after the first one. | Other | – |
Primary outcome
Age, sex, disease name and body mass index (weight in kg and height in m will be combined to report BMI in kg/m^2)
Time frame: Baseline: the outcomes are assessed before surgery
Patient characteristics and comorbidities associated with a fragility fracture of the hip
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Risk, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age, sex, disease name and body mass index (weight in kg and height in m will be combined to report BMI in kg/m^2) (time frame: Baseline: the outcomes are assessed before surgery). 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 7 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.