Bone Mineral Density Parameters Measured by DXA and Their Metabolic Determinants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Lumbar Spine-Femoral Neck T-Score Gradient
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Lumbar Spine-Femoral Neck T-Score Gradient
时间窗: 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.
次要结局
- 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)
研究者
Hatice Gözde Sümer
M.D.
Mardin Artuklu University