Chronic StrokeNCT06804252
Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients
An observational study of Chronic Stroke and Osteoporosis, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Stroke, Osteoporosis, Fragility Fractures
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients: a Prospective Observational Study
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
- Medical subject headings
- Osteoporosis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (1)
Proper screening for bone metabolism in patients after cerebrovascular event
Number of patients who were properly screened for bone metabolism after the cerebrovascular event.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start10 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804252
- Sponsor's protocol ID
- MFR022025
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06804252
- Acronym / sponsor ID
- MFR022025
- Conditions
- Chronic Stroke, Osteoporosis, Fragility Fractures
- Keywords
- chronic stroke, osteoporis, fragility fractures, Hip fractures, Stroke risk factors, Bone density (DEXA), bone, Bone mineral density
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Proper screening for bone metabolism in patients after cerebrovascular event
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stroke and Osteoporosis, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the Incidence of Osteoporosis and Fragility Fractures in Chronic Stroke Patients (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.