Health Literacy's Impact on Exercise Habits and Medication Adherence in Postmenopausal Osteoporosis

NCT ID: NCT06462833

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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postmenopausal osteoporosis

Patients followed in the Physical Medicine and Rehabilitation outpatient clinic with a diagnosis of postmenopausal osteoporosis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Ayça Utkan Karasu

Medical Doctor, Assistant Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayça Utkan Karasu, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayça Utkan Karasu, MD

Role: CONTACT

+905365759757

Levent Karataş, MD

Role: CONTACT

+905055629437

Facility Contacts

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Ayça Utkan Karasu, M.D.

Role: primary

+905365759757

Levent Karataş, MD

Role: backup

+905055629437

References

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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.

Reference Type BACKGROUND
PMID: 24113837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23595561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35745193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28421547 (View on PubMed)

Other Identifiers

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GaziU HL EH MA PO

Identifier Type: -

Identifier Source: org_study_id

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