NCT07419451

Brief Summary

Osteoporosis (OP) is defined as a progressive metabolic bone disease characterized by low bone mass and deterioration of the microarchitecture of bone tissue, resulting in increased bone fragility and a higher risk of fractures. Osteoporosis and related fractures constitute a significant public health problem in our increasingly aging world. It is currently estimated that more than 200 million people worldwide are affected by osteoporosis. The most important clinical outcome of osteoporosis is fragility fractures that occur as a result of low-energy trauma. Health literacy is an important determinant of both individual and public health and is considered a fundamental component of patient-centered care. Health literacy is defined as the ability to obtain, process, and understand relevant health information in order to make appropriate health decisions, and limited health literacy is recognized as a global public health problem. Many patients have difficulty understanding their medical conditions, medications, and care instructions due to inadequate health literacy. Patients with limited health literacy often have insufficient understanding of diagnostic and treatment protocols, which poses a risk for potential misuse of healthcare services and poorer health outcomes. Low levels of health literacy are also associated with increased hospital admissions and higher mortality rates. In contrast, higher health literacy is associated with greater health knowledge and self-confidence. Screening for the prevention of osteoporosis and related fractures can reduce fracture-associated mortality and morbidity. Such screening may be initiated by physicians through the evaluation of osteoporosis risk factors during clinical visits, or in some cases, based on patient demand, again guided by the physician's assessment of risk factors. One of the most important factors influencing patient demand is the level of osteoporosis awareness. Early diagnosis and treatment in at-risk patient groups before fractures occur can help prevent potential complications. In recent years, numerous scientific studies have investigated levels of osteoporosis knowledge and awareness. Some of these studies have focused on specific populations, such as individuals with spinal cord injury, rheumatoid arthritis, or patients followed after osteoporotic fractures, while others have been conducted exclusively among women. With increasing life expectancy and the growth of the elderly population, osteoporosis has become a more prominent health issue and is no longer limited to postmenopausal women, but rather represents a serious health problem affecting individuals of both sexes. The aim of the present study is to assess health literacy and the level of osteoporosis awareness among individuals in the age group at risk for osteoporosis and to identify factors influencing these outcomes. One of the distinguishing features of our study compared to previous research is the inclusion of both sexes. Another distinguishing aspect is the emphasis on the indication for osteoporosis screening in older adults, even in the absence of obvious risk factors such as chronic disease, medication use, or a history of fractures. We hope that our study will contribute to the existing literature on osteoporosis, health literacy, and osteoporosis awareness.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 9, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

January 24, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

osteoporosishealth literacyawareness

Outcome Measures

Primary Outcomes (2)

  • THLS-32 (Turkish Health Literacy Scale-32)

    THLS-32 (Turkish Health Literacy Scale-32) for health literacy. In this survey, the minimum score is 0 and the maximum score is 50. Higher scores indicate higher health literacy levels.

    6 months

  • Osteoporosis Awareness Scale

    "Osteoporosis Awareness Scale" for osteoporosis awareness. The total score ranges from a minimum of 27 to a maximum of 108. Although the scale has no reverse-scored items or cut-off points, higher total scores indicate greater osteoporosis awareness.

    6 months

Secondary Outcomes (6)

  • Relationship between age and THSL-32

    6 months

  • -Relationship between age and the "Osteoporosis Awareness Scale"

    6 months

  • -Relationship between gender and THSL-32

    6 months

  • -Relationship between gender and the "Osteoporosis Awareness Scale"

    6 months

  • -Relationship between education level and THSL-32

    6 months

  • +1 more secondary outcomes

Study Arms (1)

95 men and 95 women

equal number of patients of both sexes

Other: Patients will only fill out a questionnaire.

Interventions

Health literacy will be assessed using the TSOY-32 (Turkish Health Literacy Scale-32). The TSOY-32 is a 32-item questionnaire that evaluates two domains (treatment and services; disease prevention/health promotion) and four processes (accessing health-related information, understanding health-related information, appraising health-related information, and applying/using health-related information). The Turkish validity and reliability of the Health Literacy Scale used in European countries were established in 2016 by Okyay and Abacıgil, leading to the development of the TSOY-32 scale (12). Each item is rated as very easy (1), easy (2), difficult (3), very difficult (4), or "I do not know" (5). The index score is calculated using the formula "index = (mean - 1) × (50/3)," resulting in a score range of 0-50. Cut-off values are defined as follows: 0-25 "inadequate health literacy," \>25-33 "problematic/limited health literacy," \>33-42 "adequate health literacy," and \>42-50 "excellent healt

95 men and 95 women

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

One of the distinguishing features of our study compared to previous research is the inclusion of both sexes. Another distinguishing aspect is the emphasis on the indication for osteoporosis screening in older adults, even in the absence of obvious risk factors such as chronic disease, medication use, or a history of fractures.

You may qualify if:

  • Female patients aged 65 years and older
  • Male patients aged 70 years and older

You may not qualify if:

  • Cognitive dysfunction
  • Dementia
  • Uncontrolled psychiatric disorders
  • Adjustment disorders
  • Intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandırma Onyedi Eylul University Faculty of Medicine

Balıkesir, Bandırma, 10200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, Hanley DA, Hodsman A, Jamal SA, Kaiser SM, Kvern B, Siminoski K, Leslie WD; Scientific Advisory Council of Osteoporosis Canada. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ. 2010 Nov 23;182(17):1864-73. doi: 10.1503/cmaj.100771. Epub 2010 Oct 12. No abstract available.

    PMID: 20940232BACKGROUND
  • Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.

    PMID: 1421796BACKGROUND
  • Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.

    PMID: 25182228BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nurten Nas Kırdar, Dr. Öğr. Üyesi

    Bandırma Onyedi Eylül University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurten NAS KIRDAR, Dr. Öğr. Üyesi

CONTACT

Naime Meriç KONAR EROL, Associate Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 19, 2026

Study Start

July 9, 2025

Primary Completion

March 1, 2026

Study Completion

March 30, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The data analysis and results of our scientific research have not yet been completed. The final version of our study will be shared with readers by being published in an academic journal in the field of medicine. If a suitable journal deems our study suitable for publication after the peer review process, other researchers will be able to read and benefit from this publication once it is released.

Locations