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Clinical Trials/NCT06804252
NCT06804252Active, not recruitingNot Applicable

Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients: a Prospective Observational Study

University of Palermo1 site in 1 country50 target enrollmentStarted: December 10, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
50
Locations
1
Primary Endpoint
Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients

Time Frame: 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 Outcomes

  • Proper screening for bone metabolism in patients after cerebrovascular event(From enrollment to the end of treatment at 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof.ssa Giulia Letizia Mauro

Professor

University of Palermo

Study Sites (1)

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