NCT07518212

Brief 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 first stage of screening for the detection of male osteoporosis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 4, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Expected
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

February 4, 2026

Last Update Submit

April 4, 2026

Conditions

Keywords

male ostoporosisOSTMORESosteoporosis risk estimation

Outcome Measures

Primary Outcomes (3)

  • 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,"

    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.

    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

    January 2021-January 2024

Study Arms (1)

male osteoporosis group

Eligibility Criteria

Age50 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender male participant
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Education and Research Hospital

Kayseri, Kayseri, 38050, Turkey (Türkiye)

Location

Study Officials

  • Fatma Gül Ülkü Demir, MD

    Kayseri City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 4, 2026

First Posted

April 8, 2026

Study Start

February 4, 2026

Primary Completion

July 1, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations