StrokeNCT07228611
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
An observational study of Stroke and Osteoporosis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of stroke and associated clinical, functional, nutritional, and muscular factors, including handgrip strength, on bone mineral density and osteoporosis by comparing patients with subacute stroke, patients with chronic stroke, and non-stroke controls. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Osteoporosis
- What is being tested?
- Bone Mineral Density
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 1 Dec 2026
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fifty-six stroke patients receiving inpatient treatment will be evaluated. In addition, patients who have visited the outpatient clinic and have already undergone BMD scanning for osteoporosis screening, with similar age and comorbidities, will be screened from the system, and 28 non-stroke patients who agree to participate will be randomly included in the study.
Who may be able to join
- Diagnosis of ischemic or hemorrhagic stroke
- Between 1 week and 6 months or >1 year has passed since the date of the event
- Being between 55 and 85 years of age
Who cannot join
- The patient has additional neurological conditions besides stroke
- The patient has a psychiatric condition
- History of recurrent stroke
- BMD scan performed within the last year for stroke patients
- Having received osteoporosis treatment before or after the stroke
- The patient having a fragility fracture before the stroke
Show all 22Show fewer
- The patient having a hip fracture or hip prosthesis
- The patient having an additional condition that affects physical function before the stroke (amputation, severe fracture)
- The patient has an additional disease or medication use that could cause secondary osteoporosis
- The patient's stroke did not cause physical function loss Inclusion Criteria for Non-Stroke Controls
- No history of ischemic or hemorrhagic stroke.
- Being between 55 and 85 years of age.
- Ability to undergo the required clinical assessments and DXA measurements.
- Presence of a neurological condition causing significant physical functional impairment.
- Presence of a psychiatric condition that may interfere with participation in the study or completion of assessments.
- History of any cerebrovascular event, including transient ischemic attack.
- Having undergone a BMD scan within the last year.
- Having received osteoporosis treatment.
- History of fragility fracture.
- History of hip fracture or presence of a hip prosthesis.
- Presence of any medical or musculoskeletal condition causing significant physical functional impairment or mobility limitations (e.g., amputation or severe fracture).
- Presence of any disease or medication use associated with secondary osteoporosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Ayşe Naz Kalem Özgen, Specialist, +90 312 797 00 00, kalemnaz@gmail.com
About this study
Official title: Comparison of Osteoporosis Risk in the Subacute and Chronic Periods Following Stroke and Evaluation of Factors Increasing Osteoporosis
The aim of this study is to evaluate the effects of stroke and associated clinical, functional, nutritional, and muscular factors, including handgrip strength, on bone mineral density and osteoporosis by comparing patients with subacute stroke, patients with chronic stroke, and non-stroke controls. By identifying factors associated with reduced bone mineral density and osteoporosis across these groups, the study is expected to contribute to the identification of high-risk patients and provide a basis for future research aimed at improving screening and treatment strategies. No significant risks are anticipated from participation in this study.
Read the detailed description
The primary outcomes of this study will be bone mineral density (BMD), expressed in g/cm², and T-scores measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and hip. Additionally, the prevalence of osteoporosis and low bone mass will be evaluated using appropriate diagnostic criteria.
Secondary outcomes will include handgrip strength measured using a hand dynamometer, anterior thigh and anterior arm muscle thickness assessed by ultrasonography (mm), motor recovery evaluated using the Brunnstrom Recovery Stages, spasticity assessed using the Modified Ashworth Scale (MAS), functional independence measured by the Modified Barthel Index (MBI), and fall-related self-efficacy evaluated using the Modified Falls Efficacy Scale (MFES). Biochemical parameters, including serum vitamin D (ng/mL), albumin (g/dL), and prealbumin (mg/dL), will also be recorded. These outcomes will be used to investigate potential factors associated with reduced BMD and osteoporosis.
- Conditions
- Stroke, Osteoporosis
- Being tested
- Bone Mineral Density
- Medical subject headings
- Stroke, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Mineral DensityDiagnostic test
Patients who have had a stroke and are at risk of fracture, and for whom routine assessment requires Bone Mineral Density (BMD) testing, will be included in the study. In addition, patients who have already undergone BMD testing for osteoporosis screening and who present to the outpatient clinic, with similar age and comorbidities, will be screened from the system, and 28 non-stroke patients who agree to participate will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Subacute Stroke | Patients for whom 1 week to 6 months have passed since the incident Receives: Diagnostic Test: Bone Mineral Density | |
| Chronic Stroke | Patients for whom more than one year has passed since the date of the incident Receives: Diagnostic Test: Bone Mineral Density | |
| Non stroke control | Not described Receives: Diagnostic Test: Bone Mineral Density |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Bone mineral density (BMD) will be assessed in patients with stroke using dual-energy X-ray absorptiometry (DXA). Measurements will be performed at the lumbar spine and hip. BMD values will be recorded in grams per square centimeter (g/cm²), and the corresponding T-scores will also be documented for each anatomical site.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Secondary outcomes (9)
Brunnstrom
Brunnstrom Recovery Stages will be used to assess motor recovery in patients with stroke. This assessment classifies motor recovery into six stages, ranging from flaccidity (Stage I) to near-normal voluntary movement and coordination (Stage VI). The upper extremity, hand, and lower extremity will be evaluated separately, with higher stages indicating better motor recovery.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Modified Barthel Index
The Modified Barthel Index (MBI) will be used to assess functional independence in activities of daily living in patients with stroke. The index evaluates 10 activities, including feeding, bathing, dressing, toileting, transfers, and mobility. Total scores range from 0 to 100, with higher scores indicating greater functional independence.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) will be used to assess muscle spasticity in patients with stroke. The scale evaluates resistance to passive movement using six grades (0, 1, 1+, 2, 3, and 4), with higher grades indicating greater muscle tone and resistance to passive movement.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Modified Falls Efficacy Scale (MFES)
The Modified Falls Efficacy Scale (MFES) will be used to assess fall-related self-efficacy in patients with stroke. The scale consists of 14 items evaluating confidence in performing daily activities without falling. Each item is scored from 0 to 10, with higher scores indicating greater confidence and lower fear of falling.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Vitamin D
Vitamin D status will be assessed by measuring serum 25-hydroxyvitamin D [25(OH)D] levels. Results will be recorded in ng/mL and used to evaluate vitamin D status in patients with stroke.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Handgrip strength (kg)
Patients' muscle strength will be measured using a Baseline Digital Hand Dynamometer at 198 LB/90 kg for both the dominant and non-dominant extremities.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Anterior thigh and anterior arm muscle thickness (mm)
Regional sarcopenia of the plegic and non-plegic extremities will also be assessed using the STAR formula with measurements of anterior thigh muscle thickness and anterior arm muscle thickness by ultrasound.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Prealbumine
Prealbumin levels will be assessed by measuring serum prealbumin concentrations. Results will be recorded in mg/dL and used as a biochemical indicator of nutritional status in patients with stroke.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Albumine
Serum albumin levels will be measured and recorded in g/dL as a biochemical parameter reflecting nutritional and inflammatory status in patients with stroke.
Measured: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start5 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
- Investigators
- Ayşe Naz Kalem, Specialist, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228611
- Sponsor's protocol ID
- AEŞH-BADEK1-2025-478
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Osteoporosis Risk in the Subacute and Chronic Periods Following Stroke and Evaluation of Factors Increasing Osteoporosis
- ClinicalTrials.gov ID
- NCT07228611
- Acronym / sponsor ID
- AEŞH-BADEK1-2025-478
- Conditions
- Stroke, Osteoporosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Nov 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.
The aim of this study is to evaluate the effects of stroke and associated clinical, functional, nutritional, and muscular factors, including handgrip strength, on bone mineral density and osteoporosis by comparing patients with subacute stroke, patients with chronic stroke, and non-stroke controls. By identifying factors associated with reduced bone mineral density and osteoporosis across these groups, the study is expected to contribute to the identification of high-risk patients and provide a basis for future research aimed at improving screening and treatment strategies. No significant risks are anticipated from participation in this study.
Detailed description
The primary outcomes of this study will be bone mineral density (BMD), expressed in g/cm², and T-scores measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and hip. Additionally, the prevalence of osteoporosis and low bone mass will be evaluated using appropriate diagnostic criteria.
Secondary outcomes will include handgrip strength measured using a hand dynamometer, anterior thigh and anterior arm muscle thickness assessed by ultrasonography (mm), motor recovery evaluated using the Brunnstrom Recovery Stages, spasticity assessed using the Modified Ashworth Scale (MAS), functional independence measured by the Modified Barthel Index (MBI), and fall-related self-efficacy evaluated using the Modified Falls Efficacy Scale (MFES). Biochemical parameters, including serum vitamin D (ng/mL), albumin (g/dL), and prealbumin (mg/dL), will also be recorded. These outcomes will be used to investigate potential factors associated with reduced BMD and osteoporosis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subacute Stroke | – | Diagnostic Test: Bone Mineral DensityPatients for whom 1 week to 6 months have passed since the incident |
| Chronic Stroke | – | Diagnostic Test: Bone Mineral DensityPatients for whom more than one year has passed since the date of the incident |
| Non stroke control | – | Diagnostic Test: Bone Mineral Density |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty-six stroke patients receiving inpatient treatment will be evaluated. In addition, patients who have visited the outpatient clinic and have already undergone BMD scanning for osteoporosis screening, with similar age and comorbidities, will be screened from the system, and 28 non-stroke patients who agree to participate will be randomly included in the study.
Key inclusion criteria (3 listed)
- Diagnosis of ischemic or hemorrhagic stroke
- Between 1 week and 6 months or >1 year has passed since the date of the event
- Being between 55 and 85 years of age
Key exclusion criteria (22 listed)
- The patient has additional neurological conditions besides stroke
- The patient has a psychiatric condition
- History of recurrent stroke
- BMD scan performed within the last year for stroke patients
- Having received osteoporosis treatment before or after the stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Mineral DensityPatients who have had a stroke and are at risk of fracture, and for whom routine assessment requires Bone Mineral Density (BMD) testing, will be included in the study. In addition, patients who have already undergone BMD testing for osteoporosis screening and who present to the outpatient clinic, with similar age and comorbidities, will be screened from the system, and 28 non-stroke patients who agree to participate will be included in the study. | Diagnostic test | Chronic Stroke, Non stroke control, Subacute Stroke |
Primary outcome
Bone Mineral Density
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Bone mineral density (BMD) will be assessed in patients with stroke using dual-energy X-ray absorptiometry (DXA). Measurements will be performed at the lumbar spine and hip. BMD values will be recorded in grams per square centimeter (g/cm²), and the corresponding T-scores will also be documented for each anatomical site.
9 secondary outcomes
Brunnstrom
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Modified Barthel Index
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Modified Ashworth Scale
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Modified Falls Efficacy Scale (MFES)
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Vitamin D
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Handgrip strength (kg)
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Anterior thigh and anterior arm muscle thickness (mm)
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Prealbumine
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
Albumine
Time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control
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 2 Nov 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Ayşe Naz Kalem, Specialist principal investigator
Ankara Etlik City Hospital
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 Stroke and Osteoporosis, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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 Turkey (Türkiye). 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?
Contact Ayşe Naz Kalem Özgen, specialist (+90 312 797 00 00, kalemnaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: First day of hospitalization for stroke patient, during an outpatient visit for non stroke control). 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 2 Nov 2026.