AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorBursa City Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

240 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators