NCT05760118

Brief Summary

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Diabetes mellitus 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 diabetes mellitus patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

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 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

February 26, 2023

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Revised Osteoporosis Knowledge Test

    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

Secondary Outcomes (2)

  • Osteoporosis Self-Efficacy Scale

    1 day

  • Osteoporosis Health Belief Scale

    1 day

Study Arms (1)

Diabetes Mellitus Patients

Patients diagnosed with diabetes mellitus.

Other: Patient Participation Form

Interventions

A form that consists of revised osteoporosis knowledge test, osteoporosis self-efficacy scale, and osteoporosis health belief scale.

Diabetes Mellitus Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of diabetes mellitus
  • 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

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Osteoporosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Study Officials

  • Mustafa H Temel, M.D.

    Uskudar State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa H Temel, M.D.

CONTACT

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 26, 2023

First Posted

March 8, 2023

Study Start

July 1, 2023

Primary Completion

November 1, 2023

Study Completion

March 1, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05