OsteoporosisNCT07329543
AGE Burden and Response to Antiresorptive Therapy in Osteoporosis
An observational study of Osteoporosis and Postmenopausal Osteoporosis, run by Bursa City Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Postmenopausal Osteoporosis
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Osteoporosis, Postmenopausal Osteoporosis
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (4)
Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)
Percentage change in lumbar spine (L1-L4) bone mineral density from baseline to 12 months measured by DXA.
Measured: Baseline to 12 months
Serum Concentration of Bone Turnover Markers (CTX and P1NP)
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.
Measured: Baseline to 3 months and 12 months
Incident Fragility Fractures
Occurrence of new fragility fractures during the follow-up period, assessed by patient report and medical records.
Measured: Up to 12 months
Association Between Baseline AGE Burden and Treatment Response
Association between baseline AGE burden measured by skin autofluorescence and changes in bone mineral density and bone turnover markers during antiresorptive therapy.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taner Dandinoğlu, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329543
- Sponsor's protocol ID
- 2026-PMR-2
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24771986
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Advanced Glycation End-Product Burden With Response to Antiresorptive Therapy and Residual Fracture Risk in Osteoporosis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07329543
- Acronym / sponsor ID
- 2026-PMR-2
- Conditions
- Osteoporosis, Postmenopausal Osteoporosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Percentage Change in Lumbar Spine Bone Mineral Density (L1-L4)
Time frame: Baseline to 12 months
Serum Concentration of Bone Turnover Markers (CTX and P1NP)
Time frame: Baseline to 3 months and 12 months
Incident Fragility Fractures
Time frame: Up to 12 months
Association Between Baseline AGE Burden and Treatment Response
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 24771986Sanguineti 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.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Postmenopausal Osteoporosis, run by Bursa City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taner Dandinoğlu, MD (+905336914077, dandinoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Total Hip Bone Mineral Density (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.