Fragility Re-fractures Prediction Score

Osteoporosis Risk Clinical Trial

— RIFRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448325
• Other study ID #: RIFRA
• Status: Recruiting
• Start date: May 28, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: February 28, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Risk

Intervention

Other:
• Hip 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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Galeazzi-Sant'Ambrogio	Milan	Italia

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline: the outcomes are assessed before surgery