Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients

Active, not recruiting

• Conditions: Chronic Stroke; Osteoporosis; Fragility Fractures

• Registration Number: NCT06804252
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-10
• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients	From enrollment to the end of treatment at 6 months	The primary objective of this study is to evaluate the incidence of osteoporosis and fragility fractures in patients with chronic stroke.

Secondary Outcome Measures

Name	Time	Method
Proper screening for bone metabolism in patients after cerebrovascular event	From enrollment to the end of treatment at 6 months	Number of patients who were properly screened for bone metabolism after the cerebrovascular event.

Trial Locations

Locations (1)

A.O.U.P. P. Giaccone, Palermo, Italia 90127; 🇮🇹 Palermo, Italia, Italy