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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of adults aged 50 years and older with a diagnosis of osteoporosis who are initiating antiresorptive therapy as part of routine clinical care. Participants will receive either denosumab or bisphosphonate treatment according to standard clinical indications. The study will prospectively evaluate the association between baseline advanced glycation end-product (AGE) burden and treatment response, including changes in bone mineral density, bone turnover markers, and fracture outcomes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 2 trial groupsGroup A: Denosumab Group
Group B: Bisphosphonate Group
Trial outcomes
Primary outcomes
1
Percentage Change in Total Hip Bone Mineral Density
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.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)
Percentage change in lumbar spine (L1-L4) bone mineral density from baseline to 12 months measured by DXA.
Time frame
Baseline to 12 months2
Serum Concentration of Bone Turnover Markers (CTX and P1NP)
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.
Time frame
Baseline to 3 months and 12 months3
Incident Fragility Fractures
Occurrence of new fragility fractures during the follow-up period, assessed by patient report and medical records.
Time frame
Up to 12 months4
Association Between Baseline AGE Burden and Treatment Response
Association between baseline AGE burden measured by skin autofluorescence and changes in bone mineral density and bone turnover markers during antiresorptive therapy.
Time frame
Baseline to 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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