An observational study in Osteoporosis, Postmenopausal, sponsored by Gazi University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Gazi University · Observational
Postmenopausal osteoporosis is characterized by low bone mass and increased fracture risk. Treatment includes exercise, nutrition, supplements, and medications like bisphosphonates, denosumab, or hormone replacement therapy. Lifestyle changes such as quitting smoking, reducing alcohol consumption, and preventing falls are also crucial.
Despite effective treatments, adherence is low: 20-30% of patients don't start oral bisphosphonates, and 16-60% continue medications after one year. Exercise adherence rates are similarly low (14.3%-57.7%). This non-adherence imposes a significant clinical and economic burden.
Health literacy (HL)-the ability to find, understand, and use health information-is vital for managing health but is understudied in relation to osteoporosis treatment adherence. This study aims to examine the relationship between HL, exercise habits, and medication adherence in postmenopausal osteoporosis patients. Understanding these factors can lead to effective interventions, improving patient adherence and health outcomes.
The study will measure HL levels and their correlation with medication and exercise adherence, potentially informing health education programs and strategies to enhance treatment adherence. By doing so, it aims to improve health outcomes and healthcare system efficiency.
Postmenopausal osteoporosis is a common bone disease characterized by low bone mass, deterioration of bone tissue microarchitecture, and an increased risk of fractures. This condition results from the imbalance between bone formation and resorption due to decreased estrogen levels. Fractures, the feared complication of osteoporosis, make this condition a significant problem both clinically and from a public health perspective. In Europe, postmenopausal osteoporosis affects approximately 22 million women and causes over 3.5 million fragility fractures annually.
Treatment options include regular exercise, healthy nutrition, calcium and vitamin D supplementation, and pharmacological treatments such as bisphosphonates, denosumab, or hormone replacement therapy. Additionally, quitting smoking, reducing alcohol consumption, and preventing falls are crucial in preventing osteoporosis and osteoporotic fractures. Despite the availability of safe and effective medications to reduce fracture risk, many patients either do not start treatment or do not adhere to it adequately. This non-adherence to treatment results in a significant clinical and economic burden. Following the prescription of medications, a substantial percentage of patients, around 20-30%, do not start taking oral bisphosphonates, and the continuation rate of osteoporosis medications over one year is reported to range from 16% to 60%. Furthermore, low levels of adherence to resistance/weight-bearing exercises (36.3%-54.4%) and physical activity (14.3%-57.7%) have been observed.
Health literacy (HL) is defined as the capacity of individuals to find, understand, evaluate, and apply health-related information to prevent diseases, develop healthy eating behaviors, and improve their health. There are limited studies on the impact of health literacy on adherence to osteoporosis treatment in postmenopausal osteoporosis patients. However, no study has investigated the effect of HL on both medical treatment adherence and exercise adherence in postmenopausal osteoporosis patients.
This study aims to investigate the relationship between health literacy, exercise habits, and medication adherence in postmenopausal osteoporosis patients. By identifying the factors leading to non-adherence to osteoporosis-preventive medications and regular exercise, effective interventions to enhance adherence to these treatments can be determined. This can result in better health outcomes for patients and increased efficiency within the healthcare system.
337 studies on the registry are indexed under Osteoporosis, Postmenopausal; 29 are open to participants now.
This study's planned enrollment of 60 is below the median of 160 across 59 observational studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.
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Patients who have been diagnosed with postmenopausal osteoporosis and treated in the outpatient clinic for at least one year will be included in the study. Every subject meeting the criteria of inclusion is going to be included into the study via consecutive participant sampling method.
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.
Exclusion Criteria:
Patients followed in the Physical Medicine and Rehabilitation outpatient clinic with a diagnosis of postmenopausal osteoporosis.
Health literacy
Health literacy is the capacity of individuals to find, understand, evaluate, and apply health-related information to prevent diseases, develop healthy eating behaviors, and improve their health. The Turkish Health Literacy Scale-32 (THLS-32) will be used to assess the health literacy levels of the patients. THLS-32 is a 32-item Likert-type scale. Scores on the scale range from 0 indicating the lowest health literacy to 50 indicating the highest health literacy.
Time frame: Patients will be evaluated once in the baseline.
Medication adherence
The Medication Adherence Report Scale (MARS) will be used to assess medication adherence in patients. This scale consists of five different statements involving negative medication adherence behaviors, including deciding to skip doses, forgetting to take medication, changing the dosage, temporarily stopping medication intake, and taking less than prescribed. The total score on the MARS ranges from 5 to 25 points, with higher scores indicating better medication adherence
Time frame: Patients will be evaluated once in the baseline.
Physical activity
The International Physical Activity Questionnaire (IPAQ) was developed in 1998 for global physical activity surveillance. Since then, it has become the most widely used physical activity questionnaire. IPAQ-Short Form (IPAQ-SF) is a 7-item questionnaire that assesses the level of activity (low, moderate, high physical activity) in the past seven days.
Time frame: Patients will be evaluated once in the baseline.
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
Started Jul 2024 (actual). Primary completion is estimated for Oct 2024, 3 months after the start.
Of 22 observational studies under Osteoporosis, Postmenopausal, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 65. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Osteoporosis, Postmenopausal →