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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07812402
Enrollment
530
Registered
2026-09-10
Start date
2025-09-15
Completion date
2026-09-15
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, DXA, FRAX

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.

Detailed description

Osteoporosis is a progressive disease characterized by low bone mass and deterioration of bone microarchitecture. With aging, a decrease in bone strength and an increased risk of fractures occur. Osteoporosis is considered a silent disease, as it usually presents no symptoms until the first fracture occurs. The World Health Organization defines osteoporosis using a T-score derived from dual-energy X-ray absorptiometry (DXA) measurements of bone mineral density (BMD) in the hip and spine. The T-score represents a standard deviation that indicates how much a result differs from the average or mean bone mineral density. DXA measurements of hip and spinal BMD are crucial clinical tools for assessing and screening individuals at risk for osteoporosis. Dual-energy X-ray absorptiometry is the most appropriate and accessible method used to diagnose osteoporosis, assess the risk of fractures in patients, and ensure effective follow-up. However, numerous studies have pointed out the limitations of this imaging method, demonstrating that factors such as osteoarthritis, surgical implants, scoliosis, and lumbar vertebral positioning can lead to misleading results. Furthermore, previous research has reported that one of the most significant sources of error is improper patient positioning during the scan. Although DXA provides high accuracy in measuring bone mineral density, its sensitivity depends on operators, equipment, and various patient-related factors. There are numerous devices in use for DXA scanning in our country. However, the training of radiology technicians performing these scans has not yet been standardized. Some studies have reported that the rate of erroneous DXA scans is considerably high. Therefore, information regarding the impact of these erroneous scans on the diagnosis and treatment of osteoporosis remains limited. The aim of this study is to identify errors in DXA scans performed in our center and to determine how these errors affect the diagnosis and treatment decisions for osteoporosis. Estimated study duration: 6 months

Interventions

None listed

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
DXAfor 1 yearsAfter 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026