The Effect of Factors Affecting Bone Mineral Density Measurement Results on Osteoporosis Diagnosis and Treatment Decision

NCT07812402 | Active Not Recruiting

• 1 other identifier: AEŞH-BADEK-2025-0176
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-center prospective cross-sectional study with a follow-up period of 6 months. All patients met the inclusion criteria and requested DXA at the outpatient clinics of Ankara Etlik City Hospital Physical Therapy and Rehabilitation Hospital. Sample size was performed using the statistical power analysis program for G\*Power 3.1.9.6 Mac. Based on the study by Tuna et al. aiming to evaluate the rate of poor positioning of patients during DXA and the accuracy of the analysis, the minimum required number of patients (with a 95% working power and 95% confidence interval with a 5% Type 1 and 20% Type 2 margin of error and a 95% working power and 95% confidence interval) was found to be 530. It was decided to include at least 530 patients in the study.

Conditions

Osteoporosis

Keywords

osteoporosis; DXA; FRAX

Outcome Measures

Primary Outcomes (1)

• DXA

  After the scan, DXA results will be reviewed on-site, and errors in lumbar and femoral measurements will be identified separately based on the standards defined in the official measurement guide by the International Society for Clinical Densitometry. Interventions will be made during the scanning process to correct errors, and corrected reports will be generated. DXA results of erroneous and corrected scans for lumbar spine and proximal femur will be compared to assess their impact on the diagnosis and treatment of osteoporosis.

  for 1 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients included are those who met the inclusion criteria and applied to the Physical Medicine and Rehabilitation outpatient clinics of Ankara Etlik City Hospital, where a DXA scan was requested.

You may qualify if:

• Patients over 18 years of age
• Lumbar and proximal femur measurements

You may not qualify if:

• Measurements performed in children
• Forearm measurements
• Whole-body measurements
• Measurements with patient-related uncorrectable sources of error (e.g., scoliosis, stabilization materials)

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (2)

Ankara Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (1)

• Johnston CB, Dagar M. Osteoporosis in Older Adults. Med Clin North Am. 2020 Sep;104(5):873-884. doi: 10.1016/j.mcna.2020.06.004. Epub 2020 Jul 15.

  PMID: 32773051 RESULT

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yunus Burak Bayır, Principal İnvestigator

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: September 10, 2026
• Study Start: September 15, 2025
• Primary Completion: August 15, 2026
• Study Completion: September 15, 2026
• Last Updated: September 10, 2026

Record last verified: 2025-09

Locations

TU (2)