Teriparatide for acceleration of fracture repair in humans: A prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures

Abstract

Animal experiments show a dramatic improvement in skeletal repair by teriparatide. We tested the hypothesis that recombinant teriparatide, at the 20 μg dose normally used for osteoporosis treatment or higher, would accelerate fracture repair in humans. Postmenopausal women (45 to 85 years of age) who had sustained a dorsally angulated distal radial fracture in need of closed reduction but no surgery were randomly assigned to 8 weeks of once-daily injections of placebo (n=34) or teriparatide 20 μg (n=34) or teriparatide 40 mg (n=34) within 10 days of fracture. Hypotheses were tested sequentially, beginning with the teriparatide 40 μg versus placebo comparison, using a gatekeeping strategy. The estimated median time from fracture to first radiographic evidence of complete cortical bridging in three of four cortices was 9.1, 7.4, and 8.8 weeks for placebo and teriparatide 20 μg and 40μg, respectively (overall p=.015). There was no significant difference between the teriparatide 40 μg versus placebo groups (p=.523). In post hoc analyses, there was no significant difference between teriparatide 40 μg versus 20 μg (p=.053); however, the time to healing was shorter in teriparatide 20 mg than placebo (p=.006). The primary hypothesis that teriparatide 40 μg would shorten the time to cortical bridging was not supported. The shortened time to healing for teriparatide 20 μg compared with placebo still may suggest that fracture repair can be accelerated by teriparatide, but this result should be interpreted with caution and warrants further study. © 2010 American Society for Bone and Mineral Research.