Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study
Research Design and Methods: 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.
Results: 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 scans (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).
Conclusions: 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.