Osteoporosis, Postmenopausal Osteoporosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Bursa City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Total Hip Bone Mineral Density | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4) | Baseline to 12 months | Percentage change in lumbar spine (L1-L4) bone mineral density from baseline to 12 months measured by DXA. |
| Serum Concentration of Bone Turnover Markers (CTX and P1NP) | 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. |
| Incident Fragility Fractures | Up to 12 months | Occurrence of new fragility fractures during the follow-up period, assessed by patient report and medical records. |
| Association Between Baseline AGE Burden and Treatment Response | 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. |
Contacts
Primary ContactTaner Dandinoğlu, MD
Outcome results
None listed