<b>Objectives</b>:
Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite
prolonged immobilization with below-knee casting. The aim of the study was to
assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing
time to resolution of CN and healing of fractures.
<p><b>Research Design and
Methods</b>: People with diabetes and acute (active) Charcot foot were
randomized (double-blind) to either full length PTH (1-84) or placebo therapy -
both in addition to below-knee casting and Calcium and Vitamin D3
supplementation. The primary outcome was resolution of CN, defined as a skin
foot temperature difference below 2°C at two consecutive monthly visits. </p>
<p><b>Results:</b> Median time to
resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2,
9) in control. There was no significant difference in time to resolution
between the groups (mixed effects logistic regression; p=0.64). The hazard
ratio of resolution was 0.84 (95% CI 0.41, 1.74), p=0.64 and the odds ratio of
resolution by 12 months was 1.22 (0.90, 1.67), p=0.20 (intervention versus
control). On linear regression analysis, there were no significant differences
in the effect of treatment on fracture scores quantitated on magnetic resonance
imaging <a>scans </a>(coef= 0.13; 95% CI -0.62, 0.88;
p=0.73) and on foot and ankle X-rays (coef= 0.30; 95% CI -0.03, 0.63;
p=0.07). </p>
<p><b>Conclusions</b>: This
double-blind placebo-controlled trial did not reduce time to resolution or
enhance fracture healing of CN. There was no added benefit of daily intervention
with PTH (1-84) to below-knee casting in achieving earlier resolution of CN. </p>
Erratum. Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study. Diabetes Care 2021;44:1613–1621
