Metabolic Determinants of DXA-Measured Bone Mineral Density

NCT07836868 | Active Not Recruiting

• 1 other identifier: MTRH-PMR-TYY2
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Bone Mineral Density

Keywords

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

Outcome Measures

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.

  Baseline

Secondary Outcomes (5)

• Lumbar Spine-Femoral Neck Bone Mineral Density Discordance

  Baseline

• Prevalent Fragility Fracture

  Before or at the index DXA examination

• Incident Fragility Fracture

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

• FRAX 10-Year Major Osteoporotic Fracture Probability

  Baseline

• FRAX 10-Year Hip Fracture Probability

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mardin Artuklu University: lead
• Mardin Training and Research Hospital: collaborator

Study Sites (1)

Mardin Training and Research Hospital

Mardin, 47100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 20959961 BACKGROUND

• 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.

  PMID: 21723768 BACKGROUND

• 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.

  PMID: 11175911 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)