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NCT Number: NCT07518212

OST and MORES in Male Osteoporosis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Male Osteoporosis

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Kayseri City Education and Research Hospital

Kayseri, 38050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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,"

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

Performance of the Osteoporosis Self-Assessment Tool (OST) and Male Osteoporosis Risk Estimate Score (MORES) in Predicting Osteoporosis in Turkish Men

Acronym: OST and MORES

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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