The Effects of the AGE Inhibitor Pyridoxamine on Bone in Older Women With Type 2 Diabetes: A Randomized Clinical Trial
Authors' conclusion
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.
Study context
- Population
- Older women with T2D, academic center
- Participants
- 55 women
- Comparison
- Oral pyridoxamine vs placebo
- Primary endpoint
- Change in bone formation marker P1NP
- Follow-up
- 1 year
Methodological detailsdouble-blind, single academic centre
- Double-blind
- Single academic centre
Primary result
As reported in the abstract
Change in P1NP
| Group | Value | Within group P |
|---|---|---|
| Pyridoxamine (PM) | 23.0% (CI 9–37) | P = .028 |
| Placebo | 4.1% (CI −9–17) | P = .576 |
Value
Pyridoxamine (PM)23.0% (CI 9–37)
Placebo4.1% (CI −9–17)
Within group P
Pyridoxamine (PM)P = .028
PlaceboP = .576
- PM vs Placebo: between groups P = .056
Further findings
| Outcome | PM | Placebo | P value |
|---|---|---|---|
| Change in femoral neck BMD | 2.6 ± 5 % | −0.9 ± 4 % | between groups P = .007 |
| Change in HbA1c | −0.38 ± 0.7 % | 0.05 ± 1.7 % | between groups P = .04 |
Bone resorption markers and skin autofluorescence (SAF)
- Bone resorption markers and SAF did not change
Correlation of HbA1c change with % P1NP change (PM group)
- Inverse correlation, r (P = .034)
- −0.50
Correlation of cortical bone biopsy fluorescent AGEs (fAGEs) with SAF (biopsy subgroup)
- R (P = .001)
- 0.86
Safety
- Adverse events were similar between groups
Original publication
The Effects of the AGE Inhibitor Pyridoxamine on Bone in Older Women With Type 2 Diabetes: A Randomized Clinical Trial. J Clin Endocrinol Metab. Published 8 October 2024. doi:10. 1210/ clinem/ dgae700
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