NCT07402772

Brief 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 in the first stage of screening for the detection of female osteoporosis.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Status
not yet 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 Progress59%
Feb 2026Jul 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
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

February 11, 2026

Status Verified

October 1, 2025

Enrollment Period

Same day

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Female Osteoporosis

Keywords

female osteoporosisOSTORAI

Outcome Measures

Primary Outcomes (3)

  • Dual-energy X-ray absorptiometry (DEXA)

    Dual-energy X-ray absorptiometry (DEXA)

    January 2021 - January 2024

  • Osteoporosis Self-Assessment Tool (OST)

    Osteoporosis Self-Assessment Tool (OST)

    January 2021 - January 2024

  • Osteoporosis Risk Assessment Index (ORAI)

    Osteoporosis Risk Assessment Index (ORAI)

    January 2021 - January 2024

Study Arms (1)

female osteoporosis group

Eligibility Criteria

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

You may qualify if:

  • Postmenopausal women aged 50-75
  • Patients who underwent imaging with the STRATOS DEXA device at Kayseri City Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Fatma Gül ÜLKÜ DEMİR, MD

    Kayseri City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Gül Ülkü Demir, MD

CONTACT

+903523157700mdfgudemir@gmail.com

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

February 11, 2026

Study Start

February 4, 2026

Primary Completion

February 4, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

February 11, 2026

Record last verified: 2025-10