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CompletedNCT05760651Updated Apr 26, 2024

Awareness of Osteoporosis in Multiple Sclerosis Patients

An observational study in Multiple Sclerosis, Osteoporosis and Osteoporosis Risk, sponsored by Uskudar State Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Uskudar State Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
325
Ages
18 Years to 99 Years
Sex
All
01

Study 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

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

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Conditions studied

  • Multiple Sclerosis
  • Osteoporosis
  • Osteoporosis Risk
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 325 is above the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Uskudar State Hospital is the lead sponsor of 28 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not giving consent
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
325 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Multiple Sclerosis Patients

    Patients diagnosed with multiple sclerosis.

    Other: Patient Participation Form · Diagnostic Test: Timed up - and - go test

Interventions

  • OtherPatient Participation Form

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

  • Diagnostic testTimed 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 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.

    Time frame: 1 day

07

Study locations

1 site
  • Sancaktepe Şehit Doktor İlhan Varank Training and Research Hospital
    Istanbul, Sancaktepe, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — IPD will be shared upon reasonable request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2023 to primary completion in Dec 2023, 1 month.

Of 341 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's 1 month is below that.

Counting every sponsor, half of 440 studies reached it within 41 months; a quarter within 15 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2023
First posted
Mar 8, 2023
StartActual
Oct 10, 2023
Primary completionActual
Dec 1, 2023
CompletionActual
Dec 10, 2023
Last update
Apr 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05760651
Lead sponsor
Uskudar State Hospital
Responsible party
Mustafa Hüseyin Temel (Principal Investigator, Uskudar State Hospital) — Principal investigator
First posted
Mar 8, 2023
Start date
Oct 10, 2023
Primary completion
Dec 1, 2023
Completion
Dec 10, 2023
Last update
Apr 26, 2024

Study contacts

Mustafa H Temel, M.D.
principal investigator · Uskudar State Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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