AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

January 8, 2026 updated by: Taner Dandinoğlu, Bursa City Hospital

Association of Advanced Glycation End-Product Burden With Response to Antiresorptive Therapy and Residual Fracture Risk in Osteoporosis: A Prospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Denosumab Group
Patients with osteoporosis receiving denosumab as part of routine clinical care.
Bisphosphonate Group
Patients with osteoporosis receiving bisphosphonate therapy as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Total Hip Bone Mineral Density
Time Frame: 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.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)
Time Frame: Baseline to 12 months
Percentage change in lumbar spine (L1-L4) bone mineral density from baseline to 12 months measured by DXA.
Baseline to 12 months
Serum Concentration of Bone Turnover Markers (CTX and P1NP)
Time Frame: 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.
Baseline to 3 months and 12 months
Incident Fragility Fractures
Time Frame: Up to 12 months
Occurrence of new fragility fractures during the follow-up period, assessed by patient report and medical records.
Up to 12 months
Association Between Baseline AGE Burden and Treatment Response
Time Frame: 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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-PMR-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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