- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769413
Awareness of Osteoporosis in HIV Patients
May 20, 2023 updated by: Mustafa Hüseyin Temel, Uskudar State Hospital
Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density.
Patients with human immunodeficiency virus infection are at increased risk for developing osteoporosis.
Identifying whether patients with human immunodeficiency virus infection have information and awareness about this disease is crucial.
This study is aimed to investigate awareness and knowledge of osteoporosis in patients with human immunodeficiency virus infection.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Osteoporosis is a common disease of bone loss.
The reduced bone strength predisposes an increased risk for fractures in older individuals.
It can affect people from different ethnicity.
Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation.
Patients with human immunodeficiency virus infection are at high risk of developing osteoporosis due to chronic inflammation and their medications.
Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance.
This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with human immunodeficiency virus infection.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mustafa H Temel, M.D.
- Phone Number: +905342714872
- Email: mhuseyintemel@gmail.com
Study Contact Backup
- Name: Emre Ata, M.D.
- Phone Number: +905336152162
- Email: emreata.ftr@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients aged 18 to 90 years with human immunodeficiency virus infection who gave consent to participate in the study.
Description
Inclusion Criteria:
- Clinical diagnosis of human immunodeficiency virus
- Must be between the ages of 18 and 99
- Must give consent to participate in the study
Exclusion Criteria:
• Not giving consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with human immunodeficiency virus infection
|
A form that consists of revised osteoporosis knowledge test, osteoporosis self-efficacy scale, and osteoporosis health belief scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Osteoporosis Knowledge Test
Time Frame: 1 day
|
The 32-item Revised Osteoporosis Knowledge Test (ROKT; 2012), as reported by Gendler et al. (2015), is a revision of the original 24-item OKT developed by Kim, Horan, & Gendler (1991).
This measure was developed to assess the osteoporosis knowledge of adults.
Changes were made to update the original OKT to include current recommendations for calcium and vitamin D, exercise requirements, diagnosis and treatment, and a more comprehensive understanding of bone development and osteoporosis risk factors.
It contains two subscales (Nutrition and Exercise), which share 14 common items including risk factors and general knowledge.
Although the responses offered to participants are multiple choice (e.g., for risk items: more likely, less likely, neutral, don't know), there is only one correct answer for each item.
Responses are dichotomously recoded as correct or incorrect.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osteoporosis Self-Efficacy Scale
Time Frame: 1 day
|
The Osteoporosis Self-Efficacy Scale (OSES) utilizes perceived susceptibility and seriousness, perceived barriers and benefits, health motivation, and self-confidence in one's ability to take actions needed to prevent osteoporosis to predict possible occurrence of health behaviors.
|
1 day
|
Osteoporosis Health Belief Scale
Time Frame: 1 day
|
The Osteoporosis Health Belief Scale (OHBS) is a 42-item questionnaire designed to assess susceptibility, seriousness, calcium benefits, calcium barriers, exercise benefits, exercise barriers, and health motivation related to osteoporosis.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mustafa H Temel, M.D., Uskudar State Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2023
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
August 1, 2024
Study Registration Dates
First Submitted
March 3, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 20, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Slow Virus Diseases
- Bone Diseases, Metabolic
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Osteoporosis
Other Study ID Numbers
- OPHIV1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual participant data will be shared by corresponding author upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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