Osteoporosis, PostmenopausalNCT06462833
Health Literacy's Impact on Exercise Habits and Medication Adherence in Postmenopausal Osteoporosis
An observational study of Osteoporosis, Postmenopausal, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Postmenopausal patients
- Being under outpatient follow-up for osteoporosis for at least one year
Who cannot join
- Orthopedic, rheumatic, and neurological conditions that may hinder participation in exercise
- Cancer
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, Yenimahalle, 06560
Ayça Utkan Karasu, M.D., +905365759757, aycautkan@gazi.edu.tr
Levent Karataş, MD, +905055629437, dr.levent.karatas@gmail.com
About this study
Official title: The Relationship Between Health Literacy, Exercise Habits, and Medication Adherence in Postmenopausal Osteoporosis Patients
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.
Read more
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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Health Literacy, Medication Adherence, Exercise, osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Medication Adherence, Motor Activity, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal osteoporosis | Patients followed in the Physical Medicine and Rehabilitation outpatient clinic with a diagnosis of postmenopausal osteoporosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be evaluated once in the baseline.
Secondary outcomes (2)
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
Measured: 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.
Measured: Patients will be evaluated once in the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Utkan Karasu, Gazi University
- Investigators
- Ayça Utkan Karasu, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462833
- Sponsor's protocol ID
- GaziU HL EH MA PO
- Status last verified
- Sep 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 24113837Reynolds 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.
PubMed 23595561Albrecht 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.
PubMed 35745193Roh 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.
PubMed 28421547
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Health Literacy, Exercise Habits, and Medication Adherence in Postmenopausal Osteoporosis Patients
- ClinicalTrials.gov ID
- NCT06462833
- Acronym / sponsor ID
- GaziU HL EH MA PO
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Health Literacy, Medication Adherence, Exercise, osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postmenopausal osteoporosis | – | –Patients followed in the Physical Medicine and Rehabilitation outpatient clinic with a diagnosis of postmenopausal osteoporosis. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Postmenopausal patients
- Being under outpatient follow-up for osteoporosis for at least one year
Key exclusion criteria (3 listed)
- Orthopedic, rheumatic, and neurological conditions that may hinder participation in exercise
- Cancer
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health literacy
Time frame: Patients will be evaluated once in the baseline.
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.
2 secondary outcomes
Medication adherence
Time frame: Patients will be evaluated once in the baseline.
Physical activity
Time frame: Patients will be evaluated once in the baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 24113837Hernlund 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.
- Background: PubMed 23595561Reynolds 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.
- Background: PubMed 35745193Albrecht 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.
- Background: PubMed 28421547Roh 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça Utkan Karasu, MD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayça Utkan Karasu, MD (+905365759757, aycautkan@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy (time frame: Patients will be evaluated once in the baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462833, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.