- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228611
Assesment and Comparison of Osteoporosis Risk Factors After Stroke
February 22, 2026 updated by: Ayse Naz Kalem, Ankara Etlik City Hospital
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 effect of these factors and stroke itself on osteoporosis developing after stroke.
Thus, the expected benefit of the study is to contribute to the identification and determination of the need for treatment in high-risk patients through further studies.
There are no expected risks from the study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayse Naz Kalem Ozgen, Specialist
- Phone Number: +90 0312 797 00 00
- Email: kalemnaz@gmail.com
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06010
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Ayse Naz Kalem Ozgen, Specialist
- Phone Number: +90 0312 797 00 00
- Email: kalemnaz@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Followed by 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy Volunteer
|
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.
|
|
Subacute Stroke
|
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.
|
|
Chronic Stroke
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bone Mineral Density
Time Frame: First day of hospitalization
|
First day of hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brunnstrom
Time Frame: First day of hospitalization
|
First day of hospitalization
|
|
|
Modified Barthel Index
Time Frame: First day of hospitalization
|
First day of hospitalization
|
|
|
Modified Ashworth Scale
Time Frame: First day of hospitalization
|
First day of hospitalization
|
|
|
Modified Fall Impact Scale
Time Frame: First day of hospitalization
|
First day of hospitalization
|
|
|
Vitamin D, prealbumin, and albumin
Time Frame: First day of hospitalization
|
First day of hospitalization
|
|
|
Baseline Digital Hand Dynamometer 198 LB/90 kg
Time Frame: First day of hospitalization
|
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.
|
First day of hospitalization
|
|
Measurements of quadriceps muscle thickness and biceps muscle thickness
Time Frame: First day of hospitalization
|
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.
|
First day of hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Actual)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
February 24, 2026
Last Update Submitted That Met QC Criteria
February 22, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-BADEK-2025-478
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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