Association of Advanced Glycation End-Product Burden With Response to Antiresorptive Therapy and Residual Fracture Risk in Osteoporosis: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Percentage Change in Total Hip Bone Mineral Density
研究概览
简要总结
Osteoporosis is a common condition that increases the risk of bone fractures. Although antiresorptive treatments such as bisphosphonates and denosumab are effective in increasing bone mineral density, some patients continue to experience fractures despite treatment.
Advanced glycation end-products (AGEs) accumulate in the body over time and can negatively affect bone quality by altering collagen structure and increasing inflammation. The role of AGE burden in predicting response to osteoporosis treatment has not been fully established.
This prospective cohort study aims to evaluate whether baseline AGE burden, measured non-invasively using skin autofluorescence, is associated with treatment response in patients receiving antiresorptive therapy for osteoporosis. Changes in bone mineral density, bone turnover markers, and fracture outcomes will be analyzed in relation to baseline AGE levels. The results of this study may help identify patients at risk for reduced treatment response and residual fracture risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Diagnosis of osteoporosis based on dual-energy X-ray absorptiometry (DXA) criteria (T-score ≤ -2.5 at the lumbar spine, total hip, or femoral neck) or presence of a prior fragility fracture
- •Planned initiation of antiresorptive therapy (denosumab or bisphosphonate) as part of routine clinical care
- •Ability to undergo DXA measurements at baseline and during follow-up
- •Ability and willingness to provide written informed consent
排除标准
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²
- •Active malignancy or history of malignancy within the past 5 years
- •Secondary causes of osteoporosis (including hyperparathyroidism, hyperthyroidism, Cushing's syndrome, malabsorption syndromes, or chronic liver disease)
- •Use of medications known to significantly affect bone metabolism other than antiresorptive therapy (e.g., long-term systemic glucocorticoids, anabolic osteoporosis agents)
- •Prior treatment with denosumab or bisphosphonates within the last 12 months
- •Inflammatory rheumatic diseases or chronic inflammatory conditions that may affect bone metabolism
- •Pregnancy or breastfeeding
- •Inability to comply with study procedures or follow-up visits
研究组 & 干预措施
Denosumab Group
Patients with osteoporosis receiving denosumab as part of routine clinical care.
Bisphosphonate Group
Patients with osteoporosis receiving bisphosphonate therapy as part of routine clinical care.
结局指标
主要结局
Percentage Change in Total Hip Bone Mineral Density
时间窗: Baseline to 12 months
Percentage change in total hip bone mineral density (BMD) from baseline to 12 months, measured by dual-energy X-ray absorptiometry (DXA), in relation to baseline advanced glycation end-product (AGE) burden.
次要结局
- Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)(Baseline to 12 months)
- Serum Concentration of Bone Turnover Markers (CTX and P1NP)(Baseline to 3 months and 12 months)
- Incident Fragility Fractures(Up to 12 months)
- Association Between Baseline AGE Burden and Treatment Response(Baseline to 12 months)
研究者
Taner Dandinoğlu
Principal Investigator
Bursa City Hospital