OSTEOPOROSIS EDUCATION AND ITS IMPACT ON OSTEOPOROSIS HEALTH BELIEFS AND AWARENESS IN WOMEN AT RISK OF OSTEOPOROSIS

Official title

THE EFFECT OF A HEALTH BELIEF MODEL-BASED EDUCATION PROGRAMME ON OSTEOPOROSIS AWARENESS AND HEALTH BELIEFS IN WOMAN AT RISK OF OSTEOPOROSIS: A RANDOMISED CONTROLLED TRIAL

Overview

Osteoporosis is a significant public health problem characterized by low bone mass and deterioration in the microarchitecture of bone tissue, leading to an increased risk of fractures. Risk factors such as advanced age, female gender, inadequate calcium and vitamin D intake, physical inactivity, smoking, and alcohol use play a critical role in its development. As in many countries, the prevalence of osteoporosis is increasing in Turkey, accelerated by an aging population and lifestyle changes. However, it is reported that the level of awareness and knowledge about osteoporosis in the community is often insufficient. This study is a randomized controlled experimental trial with a two-group pretest-posttest design, conducted between February 1 and June 1, 2026, among women aged 45 and older who have not been diagnosed with osteoporosis but carry at least one osteoporosis risk factor, attending the Physical Therapy and Rehabilitation outpatient clinic at Bartın State Hospital. From the study population, participants who meet the inclusion criteria and volunteer will be randomly assigned to intervention and control groups. The sample size is determined as 74, calculated with a 95% confidence level and a 5% margin of error. While the intervention group receives a structured education program based on the Health Belief Model, the control group will receive no education. The dependent variables of the study are osteoporosis awareness and health beliefs. These variables will be measured before and after the intervention using the Osteoporosis Awareness Scale and the Osteoporosis Health Belief Scale, which includes subdimensions of perceived susceptibility, seriousness, benefits, and barriers. The effectiveness of the education program will be evaluated through inter-group and intra-group comparisons.

Detailed description

Osteoporosis is the most common musculoskeletal disorder worldwide, characterized by low bone mass and deterioration of the microarchitecture of bone tissue. This condition, which can lead to functional loss and increased mortality, is a significant public health problem that is both preventable and treatable. Approximately 90% of peak bone mass is achieved by age 18 in women and age 20 in men; low peak bone mass is considered a primary determinant of osteoporotic fracture risk in later life. Studies indicate that the prevalence of osteoporosis among older individuals is significant, emphasizing that the foundations of the disease are laid during adolescence.

The most serious complications of osteoporosis are fractures, which are associated with high costs, loss of independence, and mortality. These fractures most commonly occur in the spine, wrist, and hip. In postmenopausal women, wrist and spinal fractures increase after age 50, while hip fractures typically appear at later ages. Epidemiological data show varying rates of osteoporosis prevalence globally, which is notably higher in postmenopausal women. In this context, early identification of osteoporosis risk in women is critical.

Osteoporosis is classified into primary and secondary categories. Primary osteoporosis results from decreased bone mineralization due to aging or menopause, appearing more frequently 10-15 years after menopause in women and between ages 75-80 in men. Primary osteoporosis is further divided into Type 1 (postmenopausal) and Type 2 (senile). Type 1 is related to estrogen deficiency, whereas Type 2 is a natural consequence of aging, involving both cortical and trabecular bone loss. Vitamin D deficiency, decreased calcium absorption, and reduced osteoblast activity accelerate the development of Type 2. Secondary osteoporosis is associated with bone loss resulting from specific diseases or medication use.

In determining osteoporosis risk, identifying women who have not yet been diagnosed but carry specific risk factors is of vital importance. Literature reports that osteoporosis is more prevalent in women than men due to decreasing bone mineral density and increasing fragility. Primary causes include advancing age, postmenopausal estrogen decline, low body mass index, smoking, and a family history of osteoporosis. Risk factors also include modifiable and non-modifiable elements such as low calcium and vitamin D intake, inadequate physical activity, and long-term corticosteroid use. Women at risk can be defined as those who, despite lacking a formal diagnosis, possess at least one of these biological, hormonal, or lifestyle risk factors.

In addition to these factors, a lack of knowledge, misconceptions, and low awareness among women adversely affect disease prevention. Knowledge levels are often lower in rural areas, where the role of primary care physicians in information dissemination is critical. Insufficient health beliefs and knowledge levels reduce participation in screening programs and hinder early preventive measures.

According to guidelines published by global health organizations, bone density measurement is recommended for individuals at risk. This includes all women aged 65 and older, all men aged 70 and older, and younger adults with fracture risks. Furthermore, for individuals aged 50 and over, DXA screening is advised in the presence of risk factors such as a history of minimal trauma fractures, glucocorticoid therapy, postmenopausal status, low body weight (\<57 kg), family history of hip fracture, and smoking.

Organizations such as the American Association of Clinical Endocrinologists (AACE) and the National Osteoporosis Foundation (NOF) similarly recommend the routine use of DXA as a screening tool for specific age groups and clinical findings. Early diagnosis through bone density measurement, particularly in postmenopausal women and women under 65 with risk factors, is considered an effective strategy for fracture prevention. Assessing risk allows for the detection of osteoporosis during the asymptomatic stage, enabling timely preventive and therapeutic interventions. This prevents osteoporotic fractures and related complications. Individuals with a history of low-trauma fractures or those at risk for age-related bone loss should be included in regular health check-ups and monitored with bone density tests. Periodic repetition of DXA measurements is also important for monitoring treatment efficacy and assessing the progression of bone loss.

The Health Belief Model (HBM) provides an important theoretical framework for understanding the factors that shape health-related behaviors. This model focuses on the beliefs and perceptions that influence the adoption of health behaviors. The primary goal of the HBM is to explain the beliefs necessary for individuals to engage in health-promoting behaviors. In addition to individual characteristics, the model emphasizes that environmental factors play a significant role. Education and interventions can help individuals modify these perceptions, resulting in positive changes in health behaviors.

International literature features various studies using the Health Belief Model as an effective framework for explaining and guiding osteoporosis-related knowledge, attitudes, and preventive behaviors. Research indicates that following a structured education program, participants show a significant increase in awareness regarding preventive behaviors-such as exercise, vitamin D, and calcium intake-alongside positive shifts in health belief components, including perceived susceptibility, seriousness, benefits, barriers, and self-efficacy.

Interventions

• Behavioral Osteoporosis Education Based on the Health Belief Model
  Intervention Description This study evaluates a hybrid educational program based on the Health Belief Model (HBM), focusing on perceived susceptibility, severity, benefits, and barriers. 1. Baseline Assessment: Participants in both groups complete questionnaires on osteoporosis awareness and health beliefs. 2. Educational Intervention (Intervention Group): Initial Session: A 45-60 minute structured face-to-face training covering osteoporosis definition, risk factors, and prevention through

Primary outcome measures

• Change in Osteoporosis Awareness Scale (OAS) score. [Time frame: Baseline and 4 weeks post-intervention.]
• Change in Osteoporosis Health Belief Scale Score [Time frame: Baseline and 4 weeks post-intervention..]
• Change in Osteoporosis Health Belief Scale - Perceived Seriousness Sub-dimension Score. [Time frame: Baseline and 4 weeks post-intervention.]
• Change in Osteoporosis Health Belief Scale - Benefits of Exercise Sub-dimension Score. [Time frame: Baseline and 4 weeks post-intervention.]
• Change in Osteoporosis Health Belief Scale - Benefits of Calcium Intake Sub-dimension Score. [Time frame: Baseline and 4 weeks post-intervention.]
• Change in Osteoporosis Health Belief Scale - Barriers to Exercise Sub-dimension Score. [Time frame: Baseline and 4 weeks post-intervention.]
• Change in Osteoporosis Health Belief Scale - Barriers to Calcium Intake Sub-dimension Score. [Time frame: Baseline and 4 weeks post-intervention.]
• Change in Osteoporosis Health Belief Scale - Health Motivation Sub-dimension Score. [Time frame: Baseline and 4 weeks post-intervention.]
• Changes in Perceived Susceptibility Sub-dimension Score [Time frame: Baseline and 4 weeks post-intervention.]

Eligibility criteria

Inclusion criteria

• Inclusion Criteria: Individuals meeting the following criteria will be included in the study:

• Being a woman aged 45 and over
• Not having been diagnosed with osteoporosis
• Having at least one of the risk factors for osteoporosis development as stated in the literature (being in menopause, family history of osteoporosis, low level of physical activity, insufficient calcium/vitamin D intake, low body mass index, etc.)
• Having applied to the Physical Therapy and Rehabilitation Outpatient Clinic of Bartın State Hospital
• Volunteering to participate in the study and signing the informed consent form
• Having the cognitive and physical capacity to participate in the training sessions

Exclusion Criteria:Exclusion Criteria: Individuals with the following characteristics will be excluded from the study:

• Having a previous diagnosis of osteoporosis
• Having a serious endocrine or rheumatological disease affecting bone metabolism
• Having a history of long-term (≥ 3 months) systemic corticosteroid use
• Having participated in a structured education program related to osteoporosis within the last 6 months
• Having hearing, vision, or cognitive impairment that would prevent participation in the education program
• Wishing to withdraw from the study or being unable to complete the follow-up process-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Turkey (Türkiye) · 1 center

• Bartın State Hospital — Bartın

Publications

• Ocak Aktürk, S., Meseri, R., & Özentürk, M. G. (2021). The psychometric property evaluation of the Turkish version of the Osteoporosis Awareness Scale. Turkish Journal of Osteoporosis, 27(3), 151-158.https://doi.org/10.4274/tod.galenos.2021.22590
• Kılıç, D., & Erci, B. (2004). Osteoporoz sağlık ölçeği, osteoporoz öz-etkililik-yeterlik ölçeği ve osteoporoz bilgi testinin geçerlilik ve güvenirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 7(2), 89-102
• Huo R, Wei C, Huang X, Yang Y, Huo X, Meng D, Huang R, Huang Y, Zhu X, Yang Y, Lin J. Mortality associated with osteoporosis and pathological fractures in the United States (1999-2020): a multiple-cause-of-death study. J Orthop Surg Res. 2024 Sep 16;19(1):568. doi: 10.1186/s13018-024-05068-1. PMID 39285484
• Greenblatt MB, Tsai JN, Wein MN. Bone Turnover Markers in the Diagnosis and Monitoring of Metabolic Bone Disease. Clin Chem. 2017 Feb;63(2):464-474. doi: 10.1373/clinchem.2016.259085. Epub 2016 Dec 9. PMID 27940448
• Eastell R, O'Neill TW, Hofbauer LC, Langdahl B, Reid IR, Gold DT, Cummings SR. Postmenopausal osteoporosis. Nat Rev Dis Primers. 2016 Sep 29;2:16069. doi: 10.1038/nrdp.2016.69. PMID 27681935
• 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 25182228
• Camacho PM, Petak SM, Binkley N, Diab DL, Eldeiry LS, Farooki A, Harris ST, Hurley DL, Kelly J, Lewiecki EM, Pessah-Pollack R, McClung M, Wimalawansa SJ, Watts NB. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS-2020 UPDATE. Endocr Pract. 2020 May;26(Suppl 1):1-46. doi: 1 PMID 32427503
• Kanis JA, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, McCloskey EV, Willers C, Borgstrom F. SCOPE 2021: a new scorecard for osteoporosis in Europe. Arch Osteoporos. 2021 Jun 2;16(1):82. doi: 10.1007/s11657-020-00871-9. PMID 34080059

Identifiers

NCT: NCT07486076 · HBM-osteo-edu

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗