Clinical trial NCT06462833: Health Literacy's Impact on Exercise Habits and Medication Adherence in Postmenopausal Osteoporosis
Official title: The Relationship Between Health Literacy, Exercise Habits, and Medication Adherence in Postmenopausal Osteoporosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis, Postmenopausal
Keywords: Health Literacy
Medication Adherence
Exercise
osteoporosis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal patients
* Being under outpatient follow-up for osteoporosis for at least one year

Exclusion Criteria:

* Orthopedic, rheumatic, and neurological conditions that may hinder participation in exercise
* Cancer
* Refusal to participate in the study

Primary outcomes:
measure: Health literacy
timeFrame: Patients will be evaluated once in the baseline.
Secondary outcomes:
measure: Medication adherence
timeFrame: Patients will be evaluated once in the baseline.
measure: Physical activity
timeFrame: Patients will be evaluated once in the baseline.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
Study officials:
affiliation: Gazi University
name: Ayça Utkan Karasu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.
citation: Reynolds K, Muntner P, Cheetham TC, Harrison TN, Morisky DE, Silverman S, Gold DT, Vansomphone SS, Wei R, O'Malley CD. Primary non-adherence to bisphosphonates in an integrated healthcare setting. Osteoporos Int. 2013 Sep;24(9):2509-17. doi: 10.1007/s00198-013-2326-5. Epub 2013 Apr 18.
citation: Albrecht BM, Stalling I, Foettinger L, Recke C, Bammann K. Adherence to Lifestyle Recommendations for Bone Health in Older Adults with and without Osteoporosis: Cross-Sectional Results of the OUTDOOR ACTIVE Study. Nutrients. 2022 Jun 14;14(12):2463. doi: 10.3390/nu14122463.
citation: Roh YH, Koh YD, Noh JH, Gong HS, Baek GH. Effect of health literacy on adherence to osteoporosis treatment among patients with distal radius fracture. Arch Osteoporos. 2017 Dec;12(1):42. doi: 10.1007/s11657-017-0337-0. Epub 2017 Apr 18.