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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05760651
Other study ID # OPMS1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2023
Est. completion date December 10, 2023

Study information

Verified date April 2024
Source Uskudar State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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


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


Recruitment information / eligibility

Status Completed
Enrollment 325
Est. completion date December 10, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Other:
Patient Participation Form
A form that consists of revised osteoporosis knowledge test and osteoporosis awareness scale
Diagnostic Test:
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.

Locations

Country Name City State
Turkey Sancaktepe Sehit Doktor Ilhan Varank Training and Research Hospital Istanbul Sancaktepe

Sponsors (1)

Lead Sponsor Collaborator
Uskudar State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Primary 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. 1 day
Secondary 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. 1 day
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