- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402772
Female Osteoporosis (OST and ORAI)
Performance of the Osteoporosis Self-Assessment Tool (OST) and Osteoporosis Risk Assessment Index (ORAI) in Predicting Osteoporosis in Postmenopausal Turkish Women
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. 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. 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 femoral neck and total femur T scores) will be recorded. The OST score will be calculated using body weight and age parameters. The ORAI score will be calculated using age, weight, and estrogen use from hospital data.
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 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 Contact
- Name: Fatma Gül Ülkü Demir, MD
- Phone Number: +903523157700
- Email: mdfgudemir@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Postmenopausal women 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
- Male 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 |
|---|
|
female osteoporosis group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual-energy X-ray absorptiometry (DEXA)
Time Frame: January 2021 - January 2024
|
Dual-energy X-ray absorptiometry (DEXA)
|
January 2021 - January 2024
|
|
Osteoporosis Self-Assessment Tool (OST)
Time Frame: January 2021 - January 2024
|
Osteoporosis Self-Assessment Tool (OST)
|
January 2021 - January 2024
|
|
Osteoporosis Risk Assessment Index (ORAI)
Time Frame: January 2021 - January 2024
|
Osteoporosis Risk Assessment Index (ORAI)
|
January 2021 - January 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Gül Ülkü Demir, MD, Kayseri City Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Other Study ID Numbers
- Female 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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