- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07518212
OST and MORES in Male Osteoporosis (OST and MORES)
Performance of the Osteoporosis Self-Assessment Tool (OST) and Male Osteoporosis Risk Estimate Score (MORES) in Predicting Osteoporosis in Turkish Men
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Kayseri
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Kayseri, Kayseri, Turkey (Türkiye), 38050
- Kayseri City Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
İnclusion criteria:
- Men aged 50-75
- Patients who underwent imaging with the STRATOS DEXA device at Kayseri City Hospital
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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male osteoporosis group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Dual energy Xray Absorptiometry (DEXA)
Time Frame: January 2021-January 2024
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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:
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January 2021-January 2024
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MORES
Time Frame: January 2021-January 2024
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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.
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January 2021-January 2024
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OST
Time Frame: January 2021-January 2024
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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:
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January 2021-January 2024
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Gül Ülkü Demir, MD, Kayseri City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Male osteoporosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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