Multiple SclerosisNCT05760651
Awareness of Osteoporosis in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis and Osteoporosis, run by Uskudar State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis, Osteoporosis, Osteoporosis Risk
- What is being tested?
- Patient Participation Form and Timed up - and - go test
- How many people
- 325 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 10 Dec 2023
- How long will I take part?
- 1 Day
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 90 years with a diagnosis of multiple sclerosis who gave consent to participate in the study
Who may be able to join
- Clinical diagnosis of multiple sclerosis
- Must be between the ages of 18 and 99
- Must give consent to participate in the study
Who cannot join
- Not giving consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Şehit Doktor İlhan Varank Training and Research Hospital
Istanbul, Sancaktepe
About this study
Official title: Assessing Osteoporosis Awareness and Knowledge Levels In Turkish Multiple Sclerosis Patients: An Observational Study
Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in multiple sclerosis (MS) patients. The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls
Read the detailed description
Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with multiple sclerosis.The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls
- Conditions
- Multiple Sclerosis, Osteoporosis, Osteoporosis Risk
- Being tested
- Patient Participation Form, Timed up - and - go test
- Medical subject headings
- Multiple Sclerosis, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Participation FormOther
A form that consists of revised osteoporosis knowledge test and osteoporosis awareness scale
Timed up - and - go testDiagnostic test
. The timed up-and-go test involves rising from a seated position, walking a distance of 3 meters, pivoting, returning to the initial point, and resuming a sitting position. It demonstrates strong inter-rater and intra-rater reliability, offering a reliable means of quantifying functional mobility and balance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis Patients | Patients diagnosed with multiple sclerosis. Receives: Other: Patient Participation Form; Diagnostic Test: Timed up - and - go test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Osteoporosis Knowledge Test Scores
The 32-item Revised Osteoporosis Knowledge Test (ROKT; 2012), as reported by Gendler et al. (2015), is a revision of the original 24-item OKT developed by Kim, Horan, \& Gendler (1991). This measure was developed to assess the osteoporosis knowledge of adults. Changes were made to update the original OKT to include current recommendations for calcium and vitamin D, exercise requirements, diagnosis and treatment, and a more comprehensive understanding of bone development and osteoporosis risk factors. It contains two subscales (Nutrition and Exercise), which share 14 common items including risk factors and general knowledge. Although the responses offered to participants are multiple choice (e.g., for risk items: more likely, less likely, neutral, don't know), there is only one correct answer for each item. Responses are dichotomously recoded as correct or incorrect.
Measured: 1 day
Osteoporosis Awareness Scale Scores
The OAS, developed by Choi et al. in 2008, includes 31 items across 5 sub-dimensions, rated on a 4-point Likert scale. Validity and reliability assessment in Turkish was made by Aktürk et al. . The potential scores on the OAS range from a minimum of 31 to a maximum of 124. The overall osteoporosis awareness level is reflected in the mean score obtained from the entire scale, with higher scores indicating greater awareness. It's worth noting that the OAS doesn't include items with reverse scoring, and it lacks a specific cut-off point for interpretation.
Measured: 1 day
Secondary outcomes (1)
Correlation between the level of knowledge and awareness regarding osteoporosis with gender, education levels, and fall risks
Possible correlation will be analyzed using spearmans corelation test.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start10 Oct 2023
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, M.D., Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760651
- Sponsor's protocol ID
- OPMS1
- Status last verified
- Apr 2024
- First submitted
- 25 Feb 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request.
Publications
Temel MH, Tasdelen B, Demir S, Ata E. Assessing osteoporosis awareness and knowledge levels of Turkish multiple sclerosis patients: an observational study. Arch Osteoporos. 2024 Aug 1;19(1):67. doi: 10.1007/s11657-024-01426-y.
PubMed 39085698
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Osteoporosis Awareness and Knowledge Levels In Turkish Multiple Sclerosis Patients: An Observational Study
- ClinicalTrials.gov ID
- NCT05760651
- Acronym / sponsor ID
- OPMS1
- Conditions
- Multiple Sclerosis, Osteoporosis, Osteoporosis Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 8 Mar 2023 (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 condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Multiple sclerosis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in multiple sclerosis (MS) patients. The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls
Detailed description
Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with multiple sclerosis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with multiple sclerosis.The study also aimed to assess potential differences and correlations in osteoporosis knowledge and awareness among MS patients based on gender, education levels, and risk of falls
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis Patients | – | Other: Patient Participation Form, Diagnostic Test: Timed up - and - go testPatients diagnosed with multiple sclerosis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 90 years with a diagnosis of multiple sclerosis who gave consent to participate in the study
Key inclusion criteria (3 listed)
- Clinical diagnosis of multiple sclerosis
- Must be between the ages of 18 and 99
- Must give consent to participate in the study
Key exclusion criteria (1 listed)
- Not giving consent
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 |
|---|---|---|
| Patient Participation FormA form that consists of revised osteoporosis knowledge test and osteoporosis awareness scale | Other | Multiple Sclerosis Patients |
| Timed up - and - go test. The timed up-and-go test involves rising from a seated position, walking a distance of 3 meters, pivoting, returning to the initial point, and resuming a sitting position. It demonstrates strong inter-rater and intra-rater reliability, offering a reliable means of quantifying functional mobility and balance. | Diagnostic test | Multiple Sclerosis Patients |
Primary outcome
Revised Osteoporosis Knowledge Test Scores
Time frame: 1 day
The 32-item Revised Osteoporosis Knowledge Test (ROKT; 2012), as reported by Gendler et al. (2015), is a revision of the original 24-item OKT developed by Kim, Horan, \& Gendler (1991). This measure was developed to assess the osteoporosis knowledge of adults. Changes were made to update the original OKT to include current recommendations for calcium and vitamin D, exercise requirements, diagnosis and treatment, and a more comprehensive understanding of bone development and osteoporosis risk factors. It contains two subscales (Nutrition and Exercise), which share 14 common items including risk factors and general knowledge. Although the responses offered to participants are multiple choice (e.g., for risk items: more likely, less likely, neutral, don't know), there is only one correct answer for each item. Responses are dichotomously recoded as correct or incorrect.
Osteoporosis Awareness Scale Scores
Time frame: 1 day
The OAS, developed by Choi et al. in 2008, includes 31 items across 5 sub-dimensions, rated on a 4-point Likert scale. Validity and reliability assessment in Turkish was made by Aktürk et al. . The potential scores on the OAS range from a minimum of 31 to a maximum of 124. The overall osteoporosis awareness level is reflected in the mean score obtained from the entire scale, with higher scores indicating greater awareness. It's worth noting that the OAS doesn't include items with reverse scoring, and it lacks a specific cut-off point for interpretation.
1 secondary outcome
Correlation between the level of knowledge and awareness regarding osteoporosis with gender, education levels, and fall risks
Time frame: 1 day
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 26 Apr 2024.
- Derived from this study: PubMed 39085698Temel MH, Tasdelen B, Demir S, Ata E. Assessing osteoporosis awareness and knowledge levels of Turkish multiple sclerosis patients: an observational study. Arch Osteoporos. 2024 Aug 1;19(1):67. doi: 10.1007/s11657-024-01426-y.
- Individual participant dataSharing planned: Undecided. IPD will be shared 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.
Mustafa H Temel, M.D. principal investigator
Uskudar State 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 Multiple Sclerosis and Osteoporosis, run by Uskudar State 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 1 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 26 Apr 2024. 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?
Revised Osteoporosis Knowledge Test Scores (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05760651, which also lists 1 linked publication.
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 26 Apr 2024.