Type 2 & other diabetes

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

J Clin Endocrinol MetabPublished Randomised controlled 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
GroupValueWithin group P
Pyridoxamine (PM)23.0% (CI 9–37)P = .028
Placebo4.1% (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

OutcomePMPlaceboP value
Change in femoral neck BMD2.6 ± 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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