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Fragility Re-fractures Prediction Score

RIFRA - Re-fracture Risk Prediction in Patients With Fragility Fracture: Score Development and Validation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06448325
Acronym
RIFRA
Enrollment
800
Registered
2024-06-07
Start date
2024-05-28
Completion date
2025-02-28
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Risk

Brief 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. 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.

Interventions

OTHERHip arthroplasty

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.

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
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)Baseline: the outcomes are assessed before surgeryPatient characteristics and comorbidities associated with a fragility fracture of the hip

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026