Female OsteoporosisOST and ORAINCT07402772
Female Osteoporosis
An observational study of Female Osteoporosis, run by Kayseri City Hospital.
Trial summary
The aim of this study is to compare the Osteoporosis Risk Assessment Tool and the Osteoporosis Self-Assessment Tool with the gold standard DEXA in determining the risk of osteoporosis in the lumbar and femoral regions in female individuals in the Turkish population, and to investigate their sensitivity and specificity… Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Female Osteoporosis
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2026to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include female patients aged 50-75 who underwent osteoporosis screening with DEXA at the Kayseri City Hospital FTR outpatient clinics between January 2021 and January 2024.
Who may be able to join
- Postmenopausal women aged 50-75
- Patients who underwent imaging with the STRATOS DEXA device at Kayseri City Hospital
Who cannot join
- Patients younger than 50 or older than 75 years of age
- Patients with secondary osteoporosis
- Male patients
- Patients with uncontrolled severe comorbid conditions
- Patients with a history of pathological fractures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Performance of the Osteoporosis Self-Assessment Tool (OST) and Osteoporosis Risk Assessment Index (ORAI) in Predicting Osteoporosis in Postmenopausal Turkish Women
The aim of this study is to compare the Osteoporosis Risk Assessment Tool and the Osteoporosis Self-Assessment Tool with the gold standard DEXA in determining the risk of osteoporosis in the lumbar and femoral regions in female individuals in the Turkish population, and to investigate their sensitivity and specificity in the first stage of screening for the detection of female osteoporosis.
Read the detailed description
This study will be conducted as a single-center, retrospective study at the Physical Medicine and Rehabilitation Clinic of Kayseri City Hospital between January 2024 and January 2025. This study will include female patients aged 50-75 who underwent osteoporosis screening with DEXA at the Kayseri City Hospital FTR outpatient clinics between January 2021 and January 2024. Patient data will be obtained retrospectively from the hospital database. Sociodemographic data (age, height, weight, body mass index) and current laboratory data (complete blood count, biochemical values (fasting blood sugar, BUN, creatinine, AST, ALT, calcium, phosphorus, alkaline phosphatase, total protein, albumin, parathyroid hormone, vitamin D3, T4, TSH), and DEXA values (bone mineral density, lumbar vertebrae, and femoral neck and total femur T scores) will be recorded. The OST score will be calculated using body weight and age parameters. The ORAI score will be calculated using age, weight, and estrogen use from hospital data.
The data will be evaluated using the SPSS 24.0 software package. Descriptive statistical analyses will include calculations of mean, standard deviation, frequency, and percentages. In comparative statistics, the Student T-test or Mann Whitney U-test will be used to compare independent groups. Chi-square analysis will be applied to compare categorical variables. Pearson or Spearman correlation analyses will be applied to evaluate the relationship between variables. Both groups will be compared, and p<0.05 will be considered statistically significant.
- Conditions
- Female Osteoporosis
- Keywords
- female osteoporosis, OST, ORAI
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 |
|---|---|---|
| female osteoporosis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-energy X-ray absorptiometry (DEXA)
Dual-energy X-ray absorptiometry (DEXA)
Measured: January 2021 - January 2024
Osteoporosis Self-Assessment Tool (OST)
Osteoporosis Self-Assessment Tool (OST)
Measured: January 2021 - January 2024
Osteoporosis Risk Assessment Index (ORAI)
Osteoporosis Risk Assessment Index (ORAI)
Measured: January 2021 - January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start4 Feb 2026 (estimated)
- Primary completion4 Feb 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Gül Ülkü Demir, Kayseri City Hospital
- Investigators
- Fatma Gül ÜLKÜ DEMİR, MD, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402772
- Sponsor's protocol ID
- Female osteoporosis
- Acronym
- OST and ORAI
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Osteoporosis Self-Assessment Tool (OST) and Osteoporosis Risk Assessment Index (ORAI) in Predicting Osteoporosis in Postmenopausal Turkish Women
- ClinicalTrials.gov ID
- NCT07402772
- Acronym / sponsor ID
- OST and ORAI / Female osteoporosis
- Conditions
- Female Osteoporosis
- Keywords
- female osteoporosis, OST, ORAI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 4 Feb 2026 (estimated)
- Primary completion
- 4 Feb 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
The aim of this study is to compare the Osteoporosis Risk Assessment Tool and the Osteoporosis Self-Assessment Tool with the gold standard DEXA in determining the risk of osteoporosis in the lumbar and femoral regions in female individuals in the Turkish population, and to investigate their sensitivity and specificity in the first stage of screening for the detection of female osteoporosis.
Detailed description
This study will be conducted as a single-center, retrospective study at the Physical Medicine and Rehabilitation Clinic of Kayseri City Hospital between January 2024 and January 2025. This study will include female patients aged 50-75 who underwent osteoporosis screening with DEXA at the Kayseri City Hospital FTR outpatient clinics between January 2021 and January 2024. Patient data will be obtained retrospectively from the hospital database. Sociodemographic data (age, height, weight, body mass index) and current laboratory data (complete blood count, biochemical values (fasting blood sugar, BUN, creatinine, AST, ALT, calcium, phosphorus, alkaline phosphatase, total protein, albumin, parathyroid hormone, vitamin D3, T4, TSH), and DEXA values (bone mineral density, lumbar vertebrae, and femoral neck and total femur T scores) will be recorded. The OST score will be calculated using body weight and age parameters. The ORAI score will be calculated using age, weight, and estrogen use from hospital data.
The data will be evaluated using the SPSS 24.0 software package. Descriptive statistical analyses will include calculations of mean, standard deviation, frequency, and percentages. In comparative statistics, the Student T-test or Mann Whitney U-test will be used to compare independent groups. Chi-square analysis will be applied to compare categorical variables. Pearson or Spearman correlation analyses will be applied to evaluate the relationship between variables. Both groups will be compared, and p<0.05 will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female osteoporosis group | – | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include female patients aged 50-75 who underwent osteoporosis screening with DEXA at the Kayseri City Hospital FTR outpatient clinics between January 2021 and January 2024.
Key inclusion criteria (2 listed)
- Postmenopausal women aged 50-75
- Patients who underwent imaging with the STRATOS DEXA device at Kayseri City Hospital
Key exclusion criteria (5 listed)
- Patients younger than 50 or older than 75 years of age
- Patients with secondary osteoporosis
- Male patients
- Patients with uncontrolled severe comorbid conditions
- Patients with a history of pathological fractures
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
Dual-energy X-ray absorptiometry (DEXA)
Time frame: January 2021 - January 2024
Dual-energy X-ray absorptiometry (DEXA)
Osteoporosis Self-Assessment Tool (OST)
Time frame: January 2021 - January 2024
Osteoporosis Self-Assessment Tool (OST)
Osteoporosis Risk Assessment Index (ORAI)
Time frame: January 2021 - January 2024
Osteoporosis Risk Assessment Index (ORAI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided. There is not a plan to make IPD available.
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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.
Fatma Gül ÜLKÜ DEMİR, MD principal investigator
Kayseri City Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Female Osteoporosis, run by Kayseri City 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Gül Ülkü Demir, MD (+903523157700, mdfgudemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-energy X-ray absorptiometry (DEXA) (time frame: January 2021 - January 2024). The study lists 3 primary outcomes in all. 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 11 Feb 2026.