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NCT Number: NCT06804252

Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Palermo, Italia, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Proper screening for bone metabolism in patients after cerebrovascular event

    Time frame: From enrollment to the end of treatment at 6 months

    Number of patients who were properly screened for bone metabolism after the cerebrovascular event.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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