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NCT Number: NCT07836868

Metabolic Determinants of DXA-Measured Bone Mineral Density

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Bone Mineral Density Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mardin Training and Research Hospital

Mardin, 47100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lumbar Spine-Femoral Neck Bone Mineral Density Discordance

    Time frame: Baseline

    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.

  2. Prevalent Fragility Fracture

    Time frame: Before or at the index DXA examination

    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.

  3. Incident Fragility Fracture

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

    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.

  4. FRAX 10-Year Major Osteoporotic Fracture Probability

    Time frame: Baseline

    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.

  5. FRAX 10-Year Hip Fracture Probability

    Time frame: Baseline

    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.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Collaborators

  • Mardin Training and Research Hospital

Registry information

Official study title

Bone Mineral Density Parameters Measured by DXA and Their Metabolic Determinants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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