Human Immunodeficiency Virus InfectionNCT05769413
Awareness of Osteoporosis in HIV Patients
An observational study of Human Immunodeficiency Virus Infection and Osteoporosis, run by Uskudar State Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Human Immunodeficiency Virus Infection, Osteoporosis, Osteoporosis Risk
- What is being tested?
- Patient Participation Form
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Aug 2024
- How long will I take part?
- 1 Day
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients aged 18 to 90 years with human immunodeficiency virus infection who gave consent to participate in the study.
Who may be able to join
- Clinical diagnosis of human immunodeficiency virus
- Must be between the ages of 18 and 99
- Must give consent to participate in the study
Who cannot join
- Not giving consent
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Patient Participation Form
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Participation FormOther
A form that consists of revised osteoporosis knowledge test, osteoporosis self-efficacy scale, and osteoporosis health belief scale.
| Study group | Role | What they receive |
|---|---|---|
| Patients with human immunodeficiency virus infection | Patients with human immunodeficiency virus infection Receives: Other: Patient Participation Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Osteoporosis Knowledge Test
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.
Measured: 1 day
Secondary outcomes (2)
Osteoporosis Self-Efficacy Scale
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.
Measured: 1 day
Osteoporosis Health Belief Scale
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, M.D., Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769413
- Sponsor's protocol ID
- OPHIV1
- Status last verified
- May 2023
- First submitted
- 3 Mar 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be shared by corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Osteoporosis in HIV Patients
- ClinicalTrials.gov ID
- NCT05769413
- Acronym / sponsor ID
- OPHIV1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 15 Mar 2023 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with human immunodeficiency virus infection | – | Other: Patient Participation FormPatients with human immunodeficiency virus infection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 90 years with human immunodeficiency virus infection who gave consent to participate in the study.
Key inclusion criteria (3 listed)
- Clinical diagnosis of human immunodeficiency virus
- Must be between the ages of 18 and 99
- Must give consent to participate in the study
Key exclusion criteria (1 listed)
- Not giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Participation FormA form that consists of revised osteoporosis knowledge test, osteoporosis self-efficacy scale, and osteoporosis health belief scale. | Other | Patients with human immunodeficiency virus infection |
Primary outcome
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.
2 secondary outcomes
Osteoporosis Self-Efficacy Scale
Time frame: 1 day
Osteoporosis Health Belief Scale
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data will be shared by corresponding author upon reasonable request.
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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.
Mustafa H Temel, M.D. principal investigator
Uskudar State Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection and Osteoporosis, run by Uskudar State Hospital.
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 3 inclusion and 1 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 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mustafa H Temel, M.D. (+905342714872, mhuseyintemel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Osteoporosis Knowledge Test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2023.