OsteoporosisNCT07836868
Metabolic Determinants of DXA-Measured Bone Mineral Density
An observational study of Osteoporosis and Bone Mineral Density, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study will examine bone mineral density measurements and their metabolic and clinical determinants in adults aged 40 years and older. Existing medical records of approximately 300 patients who underwent dual-energy X-ray absorptiometry (DXA) of the lumbar spine and femoral neck will be… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis, Bone Mineral Density
- How many people
- 750 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Nov 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 40 years and older who underwent lumbar spine and femoral neck DXA examination at Mardin Training and Research Hospital will be identified from existing hospital records. Patients with eligible DXA measurements and available clinical and laboratory data will be included. The study population may include individuals with normal bone mineral density, osteopenia, or osteoporosis. No healthy control group will be recruited separately.
Who may be able to join
- Adults aged 40 years or older
- Lumbar spine (L1-L4) and femoral neck DXA measurements performed during the same assessment
- Available T-score and bone mineral density data from the DXA examination
- Available clinical and laboratory data required for the study analyses
Who cannot join
- Metal implant or prosthesis affecting lumbar spine or femoral neck DXA measurements
- Unreliable lumbar spine measurement due to marked artifact, surgical material, vertebral compression fracture, or extensive degenerative changes
- Fewer than two lumbar vertebrae suitable for analysis
- Active malignancy
- Stage 4 or higher chronic kidney disease
- Metabolic bone disease that may substantially affect bone mineral density
- Long-term systemic glucocorticoid use
- Missing or uninterpretable DXA data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital
Mardin, 47100
About this study
Official title: Bone Mineral Density Parameters Measured by DXA and Their Metabolic Determinants
This retrospective observational study will examine bone mineral density measurements and their metabolic and clinical determinants in adults aged 40 years and older. Existing medical records of approximately 300 patients who underwent dual-energy X-ray absorptiometry (DXA) of the lumbar spine and femoral neck will be reviewed.
The researchers will examine the relationships between DXA measurements and available clinical and laboratory findings. Differences between lumbar spine and femoral neck T-scores, bone mineral density discordance, fracture history, and FRAX fracture risk will also be evaluated. No additional examination, laboratory test, treatment, or intervention will be performed as part of the study.
Read the detailed description
Background: Bone mineral density measured at the lumbar spine and femoral neck may differ because these regions have different bone structures and may be affected differently by aging, metabolic factors, and degenerative changes. These differences may influence the diagnosis of osteoporosis and the assessment of fracture risk.
Objective: This study aims to investigate the metabolic and clinical factors associated with bone mineral density parameters measured by DXA. It will also evaluate lumbar spine-femoral neck T-score differences, bone mineral density discordance, fragility fractures, and FRAX fracture risk.
Method: This retrospective observational study will include adults aged 40 years and older who underwent DXA examination of the lumbar spine and femoral neck. Existing hospital records, DXA results, laboratory findings, and clinical information will be reviewed. The study will examine lumbar vertebral and femoral neck T-scores, the T-score difference between these regions, and concordant or discordant bone mineral density categories. Available metabolic and clinical variables will be analyzed. Previous and newly recorded fragility fractures and FRAX risk estimates will also be evaluated. No new tests or interventions will be performed.
- Conditions
- Osteoporosis, Bone Mineral Density
- Keywords
- bone mineral density, Dual-Energy X-Ray Absorptiometry, Spine-Hip Discordance, Fragility Fracture, Metabolic Determinants, FRAX
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults Undergoing DXA Assessment | Adults aged 40 years and older who underwent DXA examination of the lumbar spine and femoral neck will be included. Existing DXA measurements, clinical information, laboratory findings, fracture records, and FRAX estimates will be reviewed retrospectively. No treatment, examination, or intervention will be assigned as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Spine-Femoral Neck T-Score Gradient
The lumbar spine-femoral neck T-score gradient will be calculated by subtracting the femoral neck T-score from the mean lumbar spine T-score obtained from eligible L1-L4 vertebrae. T-scores represent the number of standard deviations by which bone mineral density differs from the young-adult reference mean. T-scores and the calculated gradient do not have predefined minimum or maximum values. Higher positive gradient values indicate a relatively higher lumbar spine T-score compared with the femoral neck, while more negative values indicate a relatively lower lumbar spine T-score. The relationships between the gradient and metabolic and clinical variables will be evaluated.
Measured: Baseline
Secondary outcomes (5)
Lumbar Spine-Femoral Neck Bone Mineral Density Discordance
Lumbar spine and femoral neck T-scores will be classified as normal (T-score ≥ -1.0), osteopenic (T-score < -1.0 and > -2.5), or osteoporotic (T-score ≤ -2.5). Participants will be classified as concordant when the lumbar spine and femoral neck are in the same diagnostic category and discordant when they are in different diagnostic categories. This is a categorical outcome reported as concordant or discordant and is not a numerical scale; therefore, it has no minimum or maximum score, and higher values do not represent a better or worse outcome.
Measured: Baseline
Prevalent Fragility Fracture
The presence of a fragility fracture before or at the time of the index DXA examination will be identified from medical records, radiology reports, and available imaging. Vertebral, hip, distal radius, and proximal humerus fractures caused by low-energy trauma will be included.
Measured: Before or at the index DXA examination
Incident Fragility Fracture
New fragility fractures occurring after the index DXA examination will be identified from medical records, radiology reports, and available imaging. Vertebral, hip, distal radius, and proximal humerus fractures caused by low-energy trauma will be included.
Measured: From the index DXA examination to the date of record review, up to 10 years
FRAX 10-Year Major Osteoporotic Fracture Probability
The 10-year probability of a major osteoporotic fracture will be calculated using the Turkey-specific Fracture Risk Assessment Tool model, with femoral neck bone mineral density and available clinical risk factors. Major osteoporotic fracture includes clinical vertebral, hip, forearm, or proximal humerus fracture. The probability is reported from 0% to 100%, with higher percentages indicating a greater 10-year risk of major osteoporotic fracture.
Measured: Baseline
FRAX 10-Year Hip Fracture Probability
The 10-year probability of hip fracture will be calculated using the Turkey-specific Fracture Risk Assessment Tool model, with femoral neck bone mineral density and available clinical risk factors. The probability is reported from 0% to 100%, with higher percentages indicating a greater 10-year risk of hip fracture.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Hatice Gözde Sümer, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836868
- Sponsor's protocol ID
- MTRH-PMR-TYY2
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leslie WD, Lix LM, Johansson H, Oden A, McCloskey E, Kanis JA. Spine-hip discordance and fracture risk assessment: a physician-friendly FRAX enhancement. Osteoporos Int. 2011 Mar;22(3):839-47. doi: 10.1007/s00198-010-1461-5. Epub 2010 Oct 20.
PubMed 20959961Leslie WD, Kovacs CS, Olszynski WP, Towheed T, Kaiser SM, Prior JC, Josse RG, Jamal SA, Kreiger N, Goltzman D; CaMos Research Group. Spine-hip T-score difference predicts major osteoporotic fracture risk independent of FRAX((R)): a population-based report from CAMOS. J Clin Densitom. 2011 Jul-Sep;14(3):286-93. doi: 10.1016/j.jocd.2011.04.011. Epub 2011 Jul 1.
PubMed 21723768Woodson G. Dual X-ray absorptiometry T-score concordance and discordance between the hip and spine measurement sites. J Clin Densitom. 2000 Winter;3(4):319-24. doi: 10.1385/jcd:3:4:319.
PubMed 11175911
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density Parameters Measured by DXA and Their Metabolic Determinants
- ClinicalTrials.gov ID
- NCT07836868
- Acronym / sponsor ID
- MTRH-PMR-TYY2
- Conditions
- Osteoporosis, Bone Mineral Density
- Keywords
- bone mineral density, Dual-Energy X-Ray Absorptiometry, Spine-Hip Discordance, Fragility Fracture, Metabolic Determinants, FRAX
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 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 retrospective observational study will examine bone mineral density measurements and their metabolic and clinical determinants in adults aged 40 years and older. Existing medical records of approximately 300 patients who underwent dual-energy X-ray absorptiometry (DXA) of the lumbar spine and femoral neck will be reviewed.
The researchers will examine the relationships between DXA measurements and available clinical and laboratory findings. Differences between lumbar spine and femoral neck T-scores, bone mineral density discordance, fracture history, and FRAX fracture risk will also be evaluated. No additional examination, laboratory test, treatment, or intervention will be performed as part of the study.
Detailed description
Background: Bone mineral density measured at the lumbar spine and femoral neck may differ because these regions have different bone structures and may be affected differently by aging, metabolic factors, and degenerative changes. These differences may influence the diagnosis of osteoporosis and the assessment of fracture risk.
Objective: This study aims to investigate the metabolic and clinical factors associated with bone mineral density parameters measured by DXA. It will also evaluate lumbar spine-femoral neck T-score differences, bone mineral density discordance, fragility fractures, and FRAX fracture risk.
Method: This retrospective observational study will include adults aged 40 years and older who underwent DXA examination of the lumbar spine and femoral neck. Existing hospital records, DXA results, laboratory findings, and clinical information will be reviewed. The study will examine lumbar vertebral and femoral neck T-scores, the T-score difference between these regions, and concordant or discordant bone mineral density categories. Available metabolic and clinical variables will be analyzed. Previous and newly recorded fragility fractures and FRAX risk estimates will also be evaluated. No new tests or interventions will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Undergoing DXA Assessment | – | –Adults aged 40 years and older who underwent DXA examination of the lumbar spine and femoral neck will be included. Existing DXA measurements, clinical information, laboratory findings, fracture records, and FRAX estimates will be reviewed retrospectively. No treatment, examination, or intervention will be assigned as part of the study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 years and older who underwent lumbar spine and femoral neck DXA examination at Mardin Training and Research Hospital will be identified from existing hospital records. Patients with eligible DXA measurements and available clinical and laboratory data will be included. The study population may include individuals with normal bone mineral density, osteopenia, or osteoporosis. No healthy control group will be recruited separately.
Key inclusion criteria (4 listed)
- Adults aged 40 years or older
- Lumbar spine (L1-L4) and femoral neck DXA measurements performed during the same assessment
- Available T-score and bone mineral density data from the DXA examination
- Available clinical and laboratory data required for the study analyses
Key exclusion criteria (8 listed)
- Metal implant or prosthesis affecting lumbar spine or femoral neck DXA measurements
- Unreliable lumbar spine measurement due to marked artifact, surgical material, vertebral compression fracture, or extensive degenerative changes
- Fewer than two lumbar vertebrae suitable for analysis
- Active malignancy
- Stage 4 or higher chronic kidney disease
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
Lumbar Spine-Femoral Neck T-Score Gradient
Time frame: Baseline
The lumbar spine-femoral neck T-score gradient will be calculated by subtracting the femoral neck T-score from the mean lumbar spine T-score obtained from eligible L1-L4 vertebrae. T-scores represent the number of standard deviations by which bone mineral density differs from the young-adult reference mean. T-scores and the calculated gradient do not have predefined minimum or maximum values. Higher positive gradient values indicate a relatively higher lumbar spine T-score compared with the femoral neck, while more negative values indicate a relatively lower lumbar spine T-score. The relationships between the gradient and metabolic and clinical variables will be evaluated.
5 secondary outcomes
Lumbar Spine-Femoral Neck Bone Mineral Density Discordance
Time frame: Baseline
Prevalent Fragility Fracture
Time frame: Before or at the index DXA examination
Incident Fragility Fracture
Time frame: From the index DXA examination to the date of record review, up to 10 years
FRAX 10-Year Major Osteoporotic Fracture Probability
Time frame: Baseline
FRAX 10-Year Hip Fracture Probability
Time frame: Baseline
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 23 Sep 2026.
- Background: PubMed 20959961Leslie WD, Lix LM, Johansson H, Oden A, McCloskey E, Kanis JA. Spine-hip discordance and fracture risk assessment: a physician-friendly FRAX enhancement. Osteoporos Int. 2011 Mar;22(3):839-47. doi: 10.1007/s00198-010-1461-5. Epub 2010 Oct 20.
- Background: PubMed 21723768Leslie WD, Kovacs CS, Olszynski WP, Towheed T, Kaiser SM, Prior JC, Josse RG, Jamal SA, Kreiger N, Goltzman D; CaMos Research Group. Spine-hip T-score difference predicts major osteoporotic fracture risk independent of FRAX((R)): a population-based report from CAMOS. J Clin Densitom. 2011 Jul-Sep;14(3):286-93. doi: 10.1016/j.jocd.2011.04.011. Epub 2011 Jul 1.
- Background: PubMed 11175911Woodson G. Dual X-ray absorptiometry T-score concordance and discordance between the hip and spine measurement sites. J Clin Densitom. 2000 Winter;3(4):319-24. doi: 10.1385/jcd:3:4:319.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Bone Mineral Density, run by Mardin Artuklu University at 1 site 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 4 inclusion and 8 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 23 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 1 site 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?
Lumbar Spine-Femoral Neck T-Score Gradient (time frame: Baseline). 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 NCT07836868, which also lists 3 linked publications.
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 23 Sep 2026.