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NCT Number: NCT07329543

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis, Postmenopausal Postmenopausal Osteoporosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Percentage Change in Total Hip Bone Mineral Density

    Time frame: 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.

Secondary outcomes

  1. Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)

    Time frame: Baseline to 12 months

    Percentage change in lumbar spine (L1-L4) bone mineral density from baseline to 12 months measured by DXA.

  2. Serum Concentration of Bone Turnover Markers (CTX and P1NP)

    Time frame: Baseline to 3 months and 12 months

    Changes in bone turnover markers, including serum C-terminal telopeptide of type I collagen (CTX) and procollagen type I N-terminal propeptide (P1NP), from baseline to 3 and 12 months.

  3. Incident Fragility Fractures

    Time frame: Up to 12 months

    Occurrence of new fragility fractures during the follow-up period, assessed by patient report and medical records.

  4. Association Between Baseline AGE Burden and Treatment Response

    Time frame: Baseline to 12 months

    Association between baseline AGE burden measured by skin autofluorescence and changes in bone mineral density and bone turnover markers during antiresorptive therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Taner Dandinoğlu, MD

CONTACT

[email protected]

+905336914077

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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