Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients

NCT06804252 | Active Not Recruiting

• 1 other identifier: MFR022025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

chronic stroke; osteoporis; fragility fractures; Hip fractures; Stroke risk factors; Bone density (DEXA); bone; Bone mineral density; Bone metabolism; Bone health; Bone health intervention; Post-stroke; Bone density screening

Outcome Measures

Primary Outcomes (1)

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

  The primary objective of this study is to evaluate the incidence of osteoporosis and fragility fractures in patients with chronic stroke.

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

• Proper screening for bone metabolism in patients after cerebrovascular event

  From enrollment to the end of treatment at 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from patients aged 65 and older who have experienced a chronic stroke and are receiving treatment at the Neurology and Rehabilitation Departments of hospitals in Palermo, Italy. The population includes both male and female patients who meet the inclusion criteria and are willing to provide informed consent. The study aims to evaluate the incidence of osteoporosis and fragility fractures in this specific population and to assess their bone metabolism management post-cerebrovascular event.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

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

Palermo, Italia, 90127, Italy

Location

MeSH Terms

Conditions

Osteoporosis; Hip Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: February 3, 2025
• Study Start: December 10, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)