Clinical trial NCT06804252: Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients
Official title: Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Proper screening for bone metabolism in patients after cerebrovascular event
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: A.O.U.P. P. Giaccone, Palermo, Italia 90127
state: Italia
Study officials:
References: