OsteoporosisNCT05738785
Risk of Osteoporotic Fracture in Home Care Patients in Turkey
An observational study of Osteoporosis and Osteoporosis Risk, run by Uskudar State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will assess the incidence of osteoporosis and osteoporotic fracture risk of registered home health patients in the Anatolian side of Istanbul. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis, Osteoporosis Risk, Osteoporotic Fractures
- What is being tested?
- Document review and scanning
- How many people
- 370 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 13 Jun 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Home care patients who have called home health services in the last 6 months.
Who may be able to join
- Being registered for home health services Having made a call to home health services in the last 6 months
Who cannot join
- Patients that have passed away
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Üsküdar State Hospital
Istanbul, Üsküdar
Mustafa H Temel, M.D., +905342714872, mhuseyintemel@gmail.com
About this study
Official title: Risk of Osteoporotic Fracture in Home Care Patients in Turkey: A Call for Action
This study will assess the incidence of osteoporosis and osteoporotic fracture risk of registered home health patients in the Anatolian side of Istanbul.
Read the detailed description
After selecting the patients who have been visited by the team in the last 6 months from the patients registered in the home health system, the number of patients required to reflect the population will be determined, and patient files will be selected by randomization. Demographic information, comorbidities, medications, and blood tests will be recorded. FRAX risks of the patients will be calculated, and it will be examined whether they have any previous fracture history and whether they have received treatment for osteoporosis.
- Conditions
- Osteoporosis, Osteoporosis Risk, Osteoporotic Fractures
- Being tested
- Document review and scanning
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Document review and scanningOther
Osteoporosis risk and osteoporotic fracture risk will be calculated by examining the patients' files.
| Study group | Role | What they receive |
|---|---|---|
| Home health care patients | Home health patients registered in the Anatolian side of Istanbul Receives: Other: Document review and scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporotic fracture risk of home care patients
Osteoporotic fracture risk of home care patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Sep 2023 (estimated)
- Primary completion13 Dec 2023 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738785
- Sponsor's protocol ID
- 1
- Status last verified
- May 2023
- First submitted
- 12 Feb 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Risk of Osteoporotic Fracture in Home Care Patients in Turkey: A Call for Action
- ClinicalTrials.gov ID
- NCT05738785
- Acronym / sponsor ID
- 1
- Conditions
- Osteoporosis, Osteoporosis Risk, Osteoporotic Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 13 Dec 2023 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 22 Feb 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.
This study will assess the incidence of osteoporosis and osteoporotic fracture risk of registered home health patients in the Anatolian side of Istanbul.
Detailed description
After selecting the patients who have been visited by the team in the last 6 months from the patients registered in the home health system, the number of patients required to reflect the population will be determined, and patient files will be selected by randomization. Demographic information, comorbidities, medications, and blood tests will be recorded. FRAX risks of the patients will be calculated, and it will be examined whether they have any previous fracture history and whether they have received treatment for osteoporosis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home health care patients | – | Other: Document review and scanningHome health patients registered in the Anatolian side of Istanbul |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Home care patients who have called home health services in the last 6 months.
Key inclusion criteria (1 listed)
- Being registered for home health services Having made a call to home health services in the last 6 months
Key exclusion criteria (1 listed)
- Patients that have passed away
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 |
|---|---|---|
| Document review and scanningOsteoporosis risk and osteoporotic fracture risk will be calculated by examining the patients' files. | Other | Home health care patients |
Primary outcome
Osteoporotic fracture risk of home care patients
Time frame: 3 months
Osteoporotic fracture risk of home care patients
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: No
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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.
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 and Osteoporosis Risk, run by Uskudar State Hospital 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 1 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.
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 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?
Osteoporotic fracture risk of home care patients (time frame: 3 months). 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.