AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

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Conditions studied: Osteoporosis, Postmenopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT07329543

Run by

Bursa City Hospital

People needed

240

Starts

2026-01-15

Expected to finish

2027-04-15

Last updated by the study team

2026-01-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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