AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

NCT07329543 | Not Yet Recruiting

• 1 other identifier: 2026-PMR-2
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis; Postmenopausal Osteoporosis

Outcome Measures

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.

  Baseline to 12 months

Secondary Outcomes (4)

• Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)

  Baseline to 12 months

• Serum Concentration of Bone Turnover Markers (CTX and P1NP)

  Baseline to 3 months and 12 months

• Incident Fragility Fractures

  Up to 12 months

• Association Between Baseline AGE Burden and Treatment Response

  Baseline to 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead

Related Publications (1)

• Sanguineti R, Puddu A, Mach F, Montecucco F, Viviani GL. Advanced glycation end products play adverse proinflammatory activities in osteoporosis. Mediators Inflamm. 2014;2014:975872. doi: 10.1155/2014/975872. Epub 2014 Mar 20.

  PMID: 24771986 RESULT

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Taner Dandinoğlu, MD

CONTACT

+905336914077; dandinoglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01