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Active, not recruitingNCT07836868Updated Sep 23, 2026

Metabolic Determinants of DXA-Measured Bone Mineral Density

An observational study in Osteoporosis and Bone Mineral Density, sponsored by Mardin Artuklu University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Mardin Artuklu University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
750
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 67 studies in Osteoporosis with a site in Turkey — 14 open to participants now, 17 under way, none of them phase 3. Osteoporosis · Turkey.

Planned enrollment
Largest of 36
750 · median 107
Started
2026
with 9 others
Observational
36 of 67
10 open now
Primary completion
2026-11
later than 12 of 16 live
Registered
66th of 67
by date

Among the 67 studies in Osteoporosis with a site in Turkey, this one has the largest planned enrollment of the 36 observational ones, is one of 10 that started in 2026, is one of 36 observational ones, reaches primary completion later than 12 of the 16 other live ones, and was the 66th registered.

By phase

67 studies; the count open now beside each. This study's row is marked.

Observationalthis study36 · 10 open
No phase26 · 3 open
Phase 34 · 0 open
Phase 41 · 1 open

By the year they started

First in 2001; this study’s year is marked. 10 started in 2026.

Size and results

Median enrollment 60 across the 31 interventional studies, 107 across the 36 observational. Of the 44 that completed or were terminated, 2 (5%) have results posted.

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02

Study 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 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.

03

Conditions studied

  • Osteoporosis
  • Bone Mineral Density

Browse trials for

Keywords

  • bone mineral density
  • Dual-Energy X-Ray Absorptiometry
  • Spine-Hip Discordance
  • Fragility Fracture
  • Metabolic Determinants
  • FRAX
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Stage 4 or higher chronic kidney disease
  • Metabolic bone disease that may substantially affect bone mineral density
  • Long-term systemic use
  • Missing or uninterpretable DXA data
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
750 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Before or at the index DXA examination

  3. 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.

    Time frame: From the index DXA examination to the date of record review, up to 10 years

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

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 20959961 ↗
  • Leslie 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 21723768 ↗
  • Woodson 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2026
First posted
Sep 23, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Nov 1, 2026
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07836868
Lead sponsor
Mardin Artuklu University
Collaborators
Mardin Training and Research Hospital
Responsible party
Hatice Gözde Sümer (M.D., Mardin Artuklu University) — Principal investigator
First posted
Sep 23, 2026
Start date
Jul 1, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Sep 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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