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Not yet recruiting NCT07329543

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

— Observational Osteoporosis Postmenopausal Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteoporosis, Postmenopausal Osteoporosis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Percentage Change in Total Hip Bone Mineral Density [Time frame: Baseline to 12 months]
Secondary outcome measures (4)
  • Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4) [Time frame: Baseline to 12 months]
  • Serum Concentration of Bone Turnover Markers (CTX and P1NP) [Time frame: Baseline to 3 months and 12 months]
  • Incident Fragility Fractures [Time frame: Up to 12 months]
  • Association Between Baseline AGE Burden and Treatment Response [Time frame: Baseline to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07329543 · 2026-PMR-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗