Male OsteoporosisOST and MORESNCT07518212
OST and MORES in Male Osteoporosis
An observational study of Male Osteoporosis, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the Male Osteoporosis Risk Score and the Osteoporosis Self-Assessment Tool with the gold standard DEXA in determining the risk of osteoporosis in the lumbar and femoral regions in male individuals in the Turkish population, and to investigate their sensitivity and specificity in the… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Male Osteoporosis
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2026to 15 Sep 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted retrospectively at the Physical Medicine and Rehabilitation Clinic of Kayseri City Hospital between January 2024 and January 2025. This study will include male patients aged 50-75 who underwent osteoporosis screening with DEXA at the Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinics between January 2021 and January 2024.
Who may be able to join
None listed.
Who cannot join
- Patients younger than 50 or older than 75 years of age
- Patients with secondary osteoporosis
- Female patients
- Patients with uncontrolled severe comorbid conditions
- Patients with a history of pathological fractures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Education and Research Hospital
Kayseri, Kayseri, 38050
About this study
Official title: Performance of the Osteoporosis Self-Assessment Tool (OST) and Male Osteoporosis Risk Estimate Score (MORES) in Predicting Osteoporosis in Turkish Men
The aim of this study is to compare the Male Osteoporosis Risk Score and the Osteoporosis Self-Assessment Tool with the gold standard DEXA in determining the risk of osteoporosis in the lumbar and femoral regions in male individuals in the Turkish population, and to investigate their sensitivity and specificity in the first stage of screening for the detection of male 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. Male patients aged 50-75 who underwent osteoporosis screening with DEXA between January 2021 and January 2024 at the FTR outpatient clinics of Kayseri City Hospital will be included in this study. 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 total T scores for the femoral neck and femur) will be recorded. The OST score will be calculated using body weight and age parameters. The MORES score will be calculated based on age, weight, and hospital data, specifically the presence of chronic obstructive pulmonary disease (COPD) with ICD-10 code: J44 and its subgroups.
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's 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
- Male Osteoporosis
- Keywords
- male ostoporosis, OST, MORES, osteoporosis risk estimation
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 |
|---|---|---|
| male osteoporosis group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual energy Xray Absorptiometry (DEXA)
DEXA measures bone mineral density (BMD; g/cm2) based on the scanned bone area. T and Z scores are used to interpret DEXA results. The T score indicates how many standard deviations below or above the average BMD measurements of a patient of the same gender and younger adults. The T score should be used for the diagnosis of osteoporosis in postmenopausal women and men over 50 years of age. The Z score indicates how many standard deviations below or above the average BMD measurements of the same gender and age. The Z score should be used for the diagnosis of osteoporosis in premenopausal women and men under 50 years of age. According to the World Health Organization's definition of bone mineral density:
- A T score between -1 and -2.5 SD indicates osteopenia.
- A T score below -2.5 SD indicates osteoporosis.
- A T score below -2.5 SD accompanied by a fragility fracture(s) indicates severe osteoporosis. • A Z-score of -2.0 SD or lower is defined as "below the expected range for age,"
Measured: January 2021-January 2024
MORES
The Male Osteoporosis Risk Prediction Score uses age, weight, and history of chronic obstructive pulmonary disease (COPD) to classify the risk of osteoporosis in men aged 50 and older. Values of 6 or higher are the threshold for screening.
Measured: January 2021-January 2024
OST
The Osteoporosis Self-Assessment Tool (OSA) screening program is used to improve osteoporosis screening in patients. The main tool of this screening program is the OS, a risk formula based on age and weight. OS has proven to be a reliable screening tool for osteoporosis in both female and male populations. The OS score is calculated using the formula: OST Score = [Weight (kg) - Age] x 0.2. Osteoporosis risk:
- High risk: -20 to -4 for women, -20 to -1 for men
- Moderate risk: -4 to -1 for women, -1 to 4 for men
- Low risk: -1 to 20 for women, -4 to 20 for men
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 posted8 Apr 2026
- Study start4 Feb 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male 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
- 140 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 Demir, MD, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518212
- Sponsor's protocol ID
- Male osteoporosis
- Acronym
- OST and MORES
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 8 Apr 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 8 Apr 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 Male Osteoporosis Risk Estimate Score (MORES) in Predicting Osteoporosis in Turkish Men
- ClinicalTrials.gov ID
- NCT07518212
- Acronym / sponsor ID
- OST and MORES / Male osteoporosis
- Conditions
- Male Osteoporosis
- Keywords
- male ostoporosis, OST, MORES, osteoporosis risk estimation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 8 Apr 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 Male Osteoporosis Risk Score and the Osteoporosis Self-Assessment Tool with the gold standard DEXA in determining the risk of osteoporosis in the lumbar and femoral regions in male individuals in the Turkish population, and to investigate their sensitivity and specificity in the first stage of screening for the detection of male 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. Male patients aged 50-75 who underwent osteoporosis screening with DEXA between January 2021 and January 2024 at the FTR outpatient clinics of Kayseri City Hospital will be included in this study. 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 total T scores for the femoral neck and femur) will be recorded. The OST score will be calculated using body weight and age parameters. The MORES score will be calculated based on age, weight, and hospital data, specifically the presence of chronic obstructive pulmonary disease (COPD) with ICD-10 code: J44 and its subgroups.
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's 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 |
|---|---|---|
| male osteoporosis group | – | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted retrospectively at the Physical Medicine and Rehabilitation Clinic of Kayseri City Hospital between January 2024 and January 2025. This study will include male patients aged 50-75 who underwent osteoporosis screening with DEXA at the Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinics between January 2021 and January 2024.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients younger than 50 or older than 75 years of age
- Patients with secondary osteoporosis
- Female 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 Xray Absorptiometry (DEXA)
Time frame: January 2021-January 2024
DEXA measures bone mineral density (BMD; g/cm2) based on the scanned bone area. T and Z scores are used to interpret DEXA results. The T score indicates how many standard deviations below or above the average BMD measurements of a patient of the same gender and younger adults. The T score should be used for the diagnosis of osteoporosis in postmenopausal women and men over 50 years of age. The Z score indicates how many standard deviations below or above the average BMD measurements of the same gender and age. The Z score should be used for the diagnosis of osteoporosis in premenopausal women and men under 50 years of age. According to the World Health Organization's definition of bone mineral density: * A T score between -1 and -2.5 SD indicates osteopenia. * A T score below -2.5 SD indicates osteoporosis. * A T score below -2.5 SD accompanied by a fragility fracture(s) indicates severe osteoporosis. • A Z-score of -2.0 SD or lower is defined as "below the expected range for age,"
MORES
Time frame: January 2021-January 2024
The Male Osteoporosis Risk Prediction Score uses age, weight, and history of chronic obstructive pulmonary disease (COPD) to classify the risk of osteoporosis in men aged 50 and older. Values of 6 or higher are the threshold for screening.
OST
Time frame: January 2021-January 2024
The Osteoporosis Self-Assessment Tool (OSA) screening program is used to improve osteoporosis screening in patients. The main tool of this screening program is the OS, a risk formula based on age and weight. OS has proven to be a reliable screening tool for osteoporosis in both female and male populations. The OS score is calculated using the formula: OST Score = [Weight (kg) - Age] x 0.2. Osteoporosis risk: * High risk: -20 to -4 for women, -20 to -1 for men * Moderate risk: -4 to -1 for women, -1 to 4 for men * Low risk: -1 to 20 for women, -4 to 20 for men
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 8 Apr 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. This study is not recruiting at the moment.
Fatma Gül Ülkü Demir, MD principal investigator
Kayseri City Hospital
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 Male Osteoporosis, run by Kayseri City 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 0 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual energy Xray 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 8 Apr 2026.