AGE Burden and Response to Antiresorptive Therapy in Osteoporosis (NCT07329543) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AGE Burden and Response to Antiresorptive Therapy in Osteoporosis
240 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Change in Total Hip Bone Mineral Density