AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Bursa City Hospital

Status

Not yet enrolling

Conditions

Postmenopausal Osteoporosis

Osteoporosis

Study type

Observational

Funder types

Other

Identifiers

NCT07329543

2026-PMR-2

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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