- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05760651
Awareness of Osteoporosis in Multiple Sclerosis Patients
April 24, 2024 updated by: Mustafa Hüseyin Temel, Uskudar State Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
325
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Sancaktepe
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Istanbul, Sancaktepe, Turkey
- Sancaktepe Şehit Doktor İlhan Varank Training and Research Hospital
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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
No
Sampling Method
Non-Probability Sample
Study Population
Patients aged 18 to 90 years with a diagnosis of multiple sclerosis who gave consent to participate in the study
Description
Inclusion Criteria:
- Clinical diagnosis of multiple sclerosis
- Must be between the ages of 18 and 99
- Must give consent to participate in the study
Exclusion Criteria:
• Not giving consent
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 |
|---|---|
|
Multiple Sclerosis Patients
Patients diagnosed with multiple sclerosis.
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A form that consists of revised osteoporosis knowledge test and osteoporosis awareness scale
. 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1 day
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Osteoporosis Awareness Scale Scores
Time Frame: 1 day
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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.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between the level of knowledge and awareness regarding osteoporosis with gender, education levels, and fall risks
Time Frame: 1 day
|
Possible correlation will be analyzed using spearmans corelation test.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mustafa H Temel, M.D., Üsküdar State 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)
October 10, 2023
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 10, 2023
Study Registration Dates
First Submitted
February 25, 2023
First Submitted That Met QC Criteria
February 25, 2023
First Posted (Actual)
March 8, 2023
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Multiple Sclerosis
- Sclerosis
- Osteoporosis
Other Study ID Numbers
- OPMS1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
IPD will be shared upon reasonable request.
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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-
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