NCT05760651

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

February 25, 2023

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Correlation between the level of knowledge and awareness regarding osteoporosis with gender, education levels, and fall risks

    1 day

Study Arms (1)

Multiple Sclerosis Patients

Patients diagnosed with multiple sclerosis.

Other: Patient Participation FormDiagnostic Test: Timed up - and - go test

Interventions

A form that consists of revised osteoporosis knowledge test and osteoporosis awareness scale

Multiple Sclerosis Patients

. 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.

Multiple Sclerosis Patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 to 90 years with a diagnosis of multiple sclerosis who gave consent to participate in the study

You may qualify if:

  • Clinical diagnosis of multiple sclerosis
  • Must be between the ages of 18 and 99
  • Must give consent to participate in the study

You may not qualify if:

  • Not giving consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Şehit Doktor İlhan Varank Training and Research Hospital

Istanbul, Sancaktepe, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple SclerosisOsteoporosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mustafa H Temel, M.D.

    Uskudar State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 8, 2023

Study Start

October 10, 2023

Primary Completion

December 1, 2023

Study Completion

December 10, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations