Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients

NCT ID: NCT06804252

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2025-08-31

Brief Summary

Stroke is a known risk factor for the development of osteoporosis, leading to an increased risk of falls and fractures. Several international studies have associated stroke with hip fractures, showing an odds ratio ranging between 1.5 and 4. The literature frequently indicates a lack of management for bone metabolism in patients following cerebrovascular events. This study aims to evaluate the incidence of osteoporosis and fragility fractures in patients with chronic stroke. A secondary aim is to assess whether patients have been adequately screened for bone metabolism following a cerebrovascular event. This study is designed as a prospective observational study. Patients aged over 65 years with chronic stroke are assessed at the U.O.C. of "Functional Recovery and Rehabilitation" at A.O.U.P. "P. Giaccone," Palermo. During the assessment, clinical and demographic data are collected, including details of the cerebrovascular event (location, hemorrhagic/ischemic, date), pre-event and post-event disability/autonomy (Rankin scale), presence of fractures (location and date) in the patient's medical history (pre and post-event), femoral and lumbar DEXA for osteoporosis evaluation, and DeFRA for assessing the 10-year risk of fragility fractures.

Conditions

Chronic Stroke; Osteoporosis; Fragility Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic Stroke Patients Aged 65 and Above

This group consists of patients aged 65 years and older who have experienced a chronic stroke. These patients are assessed for the incidence of osteoporosis and fragility fractures, and are evaluated for bone metabolism management following the cerebrovascular event. The study aims to determine the prevalence of osteoporosis and fractures, as well as the effectiveness of screening for bone metabolism disorders in this specific population.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged 65 years and older
• Diagnosed with chronic stroke
• Able to provide informed consent
• Willing to participate in follow-up assessments
• Stable medical condition that allows participation in the study

Exclusion Criteria

• Patients with acute stroke
• Severe cognitive impairment that prevents informed consent
• Other major illnesses affecting bone metabolism (e.g., severe renal disease)
• Patients already undergoing treatment for osteoporosis
• Patients with conditions that contraindicate DEXA scan

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

A.O.U.P. P. Giaccone, Palermo, Italia 90127

Palermo, Italia, Italy

Countries

Italy

Other Identifiers

MFR022025

Identifier Type: -

Identifier Source: org_study_id