OsteoporosisNCT07812402
The Effect of Factors Affecting Bone Mineral Density Measurement Results on Osteoporosis Diagnosis and Treatment Decision
An observational study of Osteoporosis, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 530 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients over 18 years of age
- Lumbar and proximal femur measurements
Who cannot join
- Measurements performed in children
- Forearm measurements
- Whole-body measurements
- Measurements with patient-related uncorrectable sources of error (e.g., scoliosis, stabilization materials)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Etlik City Hospital
Ankara, Ankara
Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
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.
Read the 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
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, DXA, FRAX
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Sep 2025
- Primary completion15 Aug 2026
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yunus Burak Bayır, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812402
- Sponsor's protocol ID
- AEŞH-BADEK-2025-0176
- Status last verified
- Sep 2025
- First submitted
- 10 May 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32773051
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Factors Affecting Bone Mineral Density Measurement Results on Osteoporosis Diagnosis and Treatment Decision
- ClinicalTrials.gov ID
- NCT07812402
- Acronym / sponsor ID
- AEŞH-BADEK-2025-0176
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, DXA, FRAX
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Lumbar and proximal femur measurements
Key exclusion criteria (4 listed)
- Measurements performed in children
- Forearm measurements
- Whole-body measurements
- Measurements with patient-related uncorrectable sources of error (e.g., scoliosis, stabilization materials)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publication: PubMed 32773051Johnston 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DXA (time frame: for 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07812402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.