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Active, not recruiting

NCT Number: NCT07812402

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital, Ankara, Turkey (Türkiye)

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. DXA

    Time frame: for 1 years

    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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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