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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ayse Naz Kalem Ozgen, Specialist
  • Phone Number: +90 0312 797 00 00
  • Email: kalemnaz@gmail.com

Study Locations

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Followed by ischemic or hemorrhagic stroke
  2. Between 1 week and 6 months or >1 year has passed since the date of the event
  3. Being between 55 and 85 years of age

Exclusion Criteria:

  1. The patient has additional neurological conditions besides stroke
  2. The patient has a psychiatric condition
  3. History of recurrent stroke
  4. BMD scan performed within the last year for stroke patients
  5. Having received osteoporosis treatment before or after the stroke
  6. The patient having a fragility fracture before the stroke
  7. The patient having a hip fracture or hip prosthesis
  8. The patient having an additional condition that affects physical function before the stroke (amputation, severe fracture)
  9. The patient has an additional disease or medication use that could cause secondary osteoporosis
  10. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Volunteer
Diagnostic test: Bone Mineral Density
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
Diagnostic test: Bone Mineral Density
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
Diagnostic test: Bone Mineral Density
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Bone Mineral Density
Time Frame: First day of hospitalization
First day of hospitalization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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