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The Effects of the AGE Inhibitor Pyridoxamine on Bone in Older Women With Type 2 Diabetes: A Randomized Clinical Trial.

Clinical visual abstract: The Effects of the AGE Inhibitor Pyridoxamine on Bone in Older Women With Type 2 Diabetes: A Randomized Clinical Trial.

Clinical Bottom Line

In a J Clin Endocrinol Metab randomized trial, PM tended to increase P1NP in older women with T2D, as well as increasing bone density and reducing HbA1c. Key reported results included P1NP increased 23.0% with PM (95% CI 9, 37; within group…

Summary: In a J Clin Endocrinol Metab randomized trial, PM tended to increase P1NP in older women with T2D, as well as increasing bone density and reducing HbA1c. Key reported results included P1NP increased 23.0% with PM (95% CI 9, 37; within group P = .028) vs 4.1% with placebo (-9, 17; within group P = .576; between groups P = .056).

PICO Summary

ElementDetail
PopulationThis was a double-blind randomized controlled trial at an academic center. Older women with T2D were included (n = 55). Oral PM 200 mg twice daily for 1 year was given. The primary outcome was the change in the bone formation marker P1NP. Other outcomes were changes in bone resorption, bone mineral density (BMD), HbA1c, and skin autofluorescence (SAF), and in a bone biopsy subgroup, the correlation between bone fluorescent…
InterventionThis was a double-blind randomized controlled trial at an academic center.
ComparisonThis was a double-blind randomized controlled trial at an academic center.
OutcomeP1NP increased 23.0% with PM (95% CI 9, 37; within group P = .028) vs 4.1% with placebo (-9, 17; within group P = .576; between groups P = .056). BMD increased at the femoral neck (PM 2.6 ± 5% vs placebo -0.9 ± 4%; between groups P = .007). Bone resorption markers and SAF did not change. HbA1c decreased (PM -0.38 ± 0.7% vs placebo 0.05 ± 1.7%; between groups P = .04). Within the PM group, the HbA1c change correlated inversely with the % P1NP change (r = -0.50, P = .034). Cortical bone biopsy fAGEs correlated with…
RCT J Clin Endocrinol Metab · 2025

The Effects of the AGE Inhibitor Pyridoxamine on Bone in...

Primary RCT · Diabetes & glycaemia

Trial design
Diabetes & glycaemia Enrolled & assessed RANDOMISED RCT Intervention Active arm n = NR Comparator Comparator n = NR P1NP increased 23.0% with PM (95% CI 9, 37; within group P = .028) vs 4.1% with placebo (-9, 17; within...
Proportion reaching endpoint
NR Reported percentage 23% Intervention 95% Comparator ARRSee PICO outcome
Reported result
23.0%
Primary abstract result
Results
23.0%
Abstract-reported estimate
Interpretation
PM tended to increase P1NP in older women with T2D, as well as increasing bone density and reducing HbA1c.
Source conclusion
Limitations
95% CI not stated
Check full paper
⬡ Bottom Line

PM tended to increase P1NP in older women with T2D, as well as increasing bone density and reducing HbA1c. Further studies are needed to investigate the potential of PM as a disease mechanism-directed approach to reduce fractures in T2D.

Expert Commentary

This J Clin Endocrinol Metab randomized trial evaluated The Effects of the AGE Inhibitor Pyridoxamine on Bone in Older Women With Type 2 Diabetes: A Randomized Clinical Trial. The abstract describes the study as follows: This was a double-blind randomized controlled trial at an academic center. Older women with T2D were included (n = 55). Oral PM 200 mg twice daily for 1 year was given. The primary outcome was the change in the bone formation marker P1NP. Other outcomes were changes in bone resorption, bone… The main reported results were: P1NP increased 23.0% with PM (95% CI 9, 37; within group P = .028) vs 4.1% with placebo (-9, 17; within group P = .576; between groups P = .056). BMD increased at the femoral neck (PM 2.6 ± 5% vs placebo -0.9 ± 4%; between groups P = .007). Bone resorption markers and SAF did not change. HbA1c decreased (PM -0.38 ± 0.7% vs placebo 0.05 ± 1.7%; between groups P = .04). Within the PM group, the HbA1c change… The authors conclude: PM tended to increase P1NP in older women with T2D, as well as increasing bone density and reducing HbA1c. Further studies are needed to investigate the potential of PM as..

References

Brossfield AV, McMahon DJ, Fernando J, et al.. The Effects of the AGE Inhibitor Pyridoxamine on Bone in Older Women With Type 2 Diabetes: A Randomized Clinical Trial.. J Clin Endocrinol Metab. 2025-Mar-17. doi:10.1210/clinem/dgae700. PMID: 39376018.

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