Spinal Cord Injuries (SCI)NCT07725081
Osteoporosis Awareness in Chronic Spinal Cord Injury
An observational study of Spinal Cord Injuries (SCI) and Osteoporosis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Osteoporosis is a common and serious complication of spinal cord injury (SCI), substantially increasing the risk of fragility fractures. Despite this elevated risk, awareness of osteoporosis among individuals living with SCI is not well understood. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Cord Injuries (SCI), Osteoporosis, Health Knowledge
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 25 Mar 2024
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic traumatic spinal cord injuries who were under outpatient care at a tertiary physical medicine and rehabilitation center in Turkey between December 20, 2023, and March 20, 2024.
Who may be able to join
- Documented traumatic spinal cord injury
- Injury duration of at least 12 months (chronic SCI)
- Age 18 years or older
- Able to provide informed consent and complete questionnaires in Turkish
Who cannot join
- Significant cognitive impairment precluding reliable questionnaire completion
- Acute medical illness requiring hospitalization
- Inability to communicate in Turkish
- Non-traumatic etiology of spinal cord injury
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Afyonkarahisar, 03030
About this study
Official title: Osteoporosis Awareness in Individuals With Chronic Spinal Cord Injury: Factors Associated With Education and Health-Seeking Behaviors
Osteoporosis is a common and serious complication of spinal cord injury (SCI), substantially increasing the risk of fragility fractures. Despite this elevated risk, awareness of osteoporosis among individuals living with SCI is not well understood. This cross-sectional observational study assessed the level of osteoporosis awareness in adults with chronic traumatic SCI and examined which demographic, injury-related, and healthcare-related factors were independently associated with awareness. Ninety-four adults with chronic traumatic SCI completed the Turkish version of the Osteoporosis Awareness Scale, along with a structured questionnaire covering education, injury characteristics, healthcare utilization, and personal health-seeking behaviors. The study aimed to identify modifiable factors linked to higher awareness in order to inform future educational interventions and improve osteoporosis prevention and management in this high-risk population.
Read the detailed description
Background: Individuals with spinal cord injury (SCI) experience rapid and severe sublesional bone loss, with fracture rates several-fold higher than in the general population. Patient awareness is an important determinant of preventive behavior, screening participation, and treatment adherence, yet the factors shaping osteoporosis awareness in the SCI population have not been systematically investigated, and no such data exist for the Turkish SCI population.
Objectives: The study aimed to (1) assess osteoporosis awareness among individuals with chronic SCI using a validated instrument; (2) examine bivariate associations between potential predictors and awareness; and (3) identify factors independently associated with awareness through multivariable regression.
Design and Setting: This was a single-center, cross-sectional observational study conducted at a tertiary physical medicine and rehabilitation center between January and December 2023.
Participants: Ninety-four adults with documented traumatic SCI of at least 12 months' duration were enrolled through consecutive sampling. Individuals with significant cognitive impairment, acute illness requiring hospitalization, or inability to complete questionnaires in Turkish were excluded. Only traumatic SCI cases were included.
Measures: Osteoporosis awareness was assessed using the Turkish version of the Osteoporosis Awareness Scale (31 items; total score range 31 to 124). Additional data included age, sex, education level, injury level and completeness, ASIA Impairment Scale grade, injury duration, fracture history, regular follow-up, receipt of osteoporosis education, personal research, bone density testing history, and use of bone-relevant medications.
Statistical Analysis: Bivariate analyses used t-tests, one-way ANOVA, and correlation coefficients, with effect sizes reported. Multiple linear regression with nine predictors identified factors independently associated with awareness. Regression diagnostics and a sensitivity analysis were performed to confirm robustness.
- Conditions
- Spinal Cord Injuries (SCI), Osteoporosis, Health Knowledge, Attitudes, Patient Education as Topic, Practice
- Keywords
- spinal cord injury, osteoporosis, osteoporosis awareness, health knowledge, attitudes, practice, health literacy, patient education, bone density, fracture prevention, rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis, Behavior
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 |
|---|---|---|
| Adults with chronic traumatic spinal cord injury | Adults (aged 18 years or older) with documented traumatic spinal cord injury of at least 12 months' duration, recruited consecutively during outpatient follow-up. Participants completed the Turkish version of the Osteoporosis Awareness Scale together with a structured questionnaire on demographic, injury-related, and healthcare-related characteristics. No intervention was applied; participants were assessed at a single time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of osteoporosis awareness
Osteoporosis awareness was measured using the total score of the Turkish version of the Osteoporosis Awareness Scale (OAS), a 31-item instrument rated on a 4-point Likert scale, with total scores ranging from 31 to 124. Higher scores indicate greater osteoporosis awareness. The scale was administered once, at study enrollment.
Measured: At a single time point (baseline assessment)
Secondary outcomes (2)
Factors independently associated with osteoporosis awareness
Demographic, injury-related, and healthcare-related factors independently associated with OAS total scores, assessed by multiple linear regression. Candidate factors included age, sex, education level, injury duration, ASIA Impairment Scale grade, fracture history, regular osteoporosis-related follow-up, personal research, and receipt of osteoporosis education.
Measured: At a single time point (baseline assessment)
Osteoporosis-related healthcare utilization and health-seeking behaviors
Proportions of participants reporting regular osteoporosis-related follow-up, prior receipt of osteoporosis education, personal research on osteoporosis, prior bone density (DXA) testing, and awareness of DXA scanning, assessed by structured questionnaire.
Measured: At a single time point (baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Dec 2023
- Primary completion20 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies 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
- Cross-sectional
- Enrolment
- 94 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Beştaş, Afyonkarahisar Health Sciences University
- Investigators
- ERSİN BEŞTAŞ, MD, Principal investigator, Afyonkarahisar Health Sciences University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725081
- Sponsor's protocol ID
- AFSU-PMR-2023-565
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly available due to privacy and ethical restrictions but may be obtained from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Awareness in Individuals With Chronic Spinal Cord Injury: Factors Associated With Education and Health-Seeking Behaviors
- ClinicalTrials.gov ID
- NCT07725081
- Acronym / sponsor ID
- AFSU-PMR-2023-565
- Conditions
- Spinal Cord Injuries (SCI), Osteoporosis, Health Knowledge, Attitudes, Patient Education as Topic, Practice
- Keywords
- spinal cord injury, osteoporosis, osteoporosis awareness, health knowledge, attitudes, practice, health literacy, patient education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 24 Jul 2026 (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.
Osteoporosis is a common and serious complication of spinal cord injury (SCI), substantially increasing the risk of fragility fractures. Despite this elevated risk, awareness of osteoporosis among individuals living with SCI is not well understood. This cross-sectional observational study assessed the level of osteoporosis awareness in adults with chronic traumatic SCI and examined which demographic, injury-related, and healthcare-related factors were independently associated with awareness. Ninety-four adults with chronic traumatic SCI completed the Turkish version of the Osteoporosis Awareness Scale, along with a structured questionnaire covering education, injury characteristics, healthcare utilization, and personal health-seeking behaviors. The study aimed to identify modifiable factors linked to higher awareness in order to inform future educational interventions and improve osteoporosis prevention and management in this high-risk population.
Detailed description
Background: Individuals with spinal cord injury (SCI) experience rapid and severe sublesional bone loss, with fracture rates several-fold higher than in the general population. Patient awareness is an important determinant of preventive behavior, screening participation, and treatment adherence, yet the factors shaping osteoporosis awareness in the SCI population have not been systematically investigated, and no such data exist for the Turkish SCI population.
Objectives: The study aimed to (1) assess osteoporosis awareness among individuals with chronic SCI using a validated instrument; (2) examine bivariate associations between potential predictors and awareness; and (3) identify factors independently associated with awareness through multivariable regression.
Design and Setting: This was a single-center, cross-sectional observational study conducted at a tertiary physical medicine and rehabilitation center between January and December 2023.
Participants: Ninety-four adults with documented traumatic SCI of at least 12 months' duration were enrolled through consecutive sampling. Individuals with significant cognitive impairment, acute illness requiring hospitalization, or inability to complete questionnaires in Turkish were excluded. Only traumatic SCI cases were included.
Measures: Osteoporosis awareness was assessed using the Turkish version of the Osteoporosis Awareness Scale (31 items; total score range 31 to 124). Additional data included age, sex, education level, injury level and completeness, ASIA Impairment Scale grade, injury duration, fracture history, regular follow-up, receipt of osteoporosis education, personal research, bone density testing history, and use of bone-relevant medications.
Statistical Analysis: Bivariate analyses used t-tests, one-way ANOVA, and correlation coefficients, with effect sizes reported. Multiple linear regression with nine predictors identified factors independently associated with awareness. Regression diagnostics and a sensitivity analysis were performed to confirm robustness.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with chronic traumatic spinal cord injury | – | –Adults (aged 18 years or older) with documented traumatic spinal cord injury of at least 12 months' duration, recruited consecutively during outpatient follow-up. Participants completed the Turkish version of the Osteoporosis Awareness Scale together with a structured questionnaire on demographic, injury-related, and healthcare-related characteristics. No intervention was applied; participants were assessed at a single time point. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic traumatic spinal cord injuries who were under outpatient care at a tertiary physical medicine and rehabilitation center in Turkey between December 20, 2023, and March 20, 2024.
Key inclusion criteria (4 listed)
- Documented traumatic spinal cord injury
- Injury duration of at least 12 months (chronic SCI)
- Age 18 years or older
- Able to provide informed consent and complete questionnaires in Turkish
Key exclusion criteria (4 listed)
- Significant cognitive impairment precluding reliable questionnaire completion
- Acute medical illness requiring hospitalization
- Inability to communicate in Turkish
- Non-traumatic etiology of spinal cord injury
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
Level of osteoporosis awareness
Time frame: At a single time point (baseline assessment)
Osteoporosis awareness was measured using the total score of the Turkish version of the Osteoporosis Awareness Scale (OAS), a 31-item instrument rated on a 4-point Likert scale, with total scores ranging from 31 to 124. Higher scores indicate greater osteoporosis awareness. The scale was administered once, at study enrollment.
2 secondary outcomes
Factors independently associated with osteoporosis awareness
Time frame: At a single time point (baseline assessment)
Osteoporosis-related healthcare utilization and health-seeking behaviors
Time frame: At a single time point (baseline assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data are not publicly available due to privacy and ethical restrictions but may be obtained from the corresponding author upon 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. This study is not recruiting at the moment.
ERSİN BEŞTAŞ, MD principal investigator
Afyonkarahisar Health Sciences University, Faculty of Medicine
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 Spinal Cord Injuries (SCI) and Osteoporosis, run by Afyonkarahisar Health Sciences University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of osteoporosis awareness (time frame: At a single time point (baseline assessment)). 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 24 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.