AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Официальное название

Association of Advanced Glycation End-Product Burden With Response to Antiresorptive Therapy and Residual Fracture Risk in Osteoporosis: A Prospective Cohort Study

Обзор

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.

Первичные конечные точки

• Percentage Change in Total Hip Bone Mineral Density [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (4)

• Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4) [Срок оценки: Baseline to 12 months]
• Serum Concentration of Bone Turnover Markers (CTX and P1NP) [Срок оценки: Baseline to 3 months and 12 months]
• Incident Fragility Fractures [Срок оценки: Up to 12 months]
• Association Between Baseline AGE Burden and Treatment Response [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Sanguineti R, Puddu A, Mach F, Montecucco F, Viviani GL. Advanced glycation end products play adverse proinflammatory activities in osteoporosis. Mediators Inflamm. 2014;2014:975872. doi: 10.1155/2014/975872. Epub 2014 Mar 20. PMID 24771986

Идентификаторы

NCT: NCT07329543 · 2026-PMR-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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