Teriparatide and Pelvic Fracture Healing: A Phase 2 Randomized Controlled Trial

Abstract

Purpose: To determine if teriparatide (20 ug/day; TPTD) results in improved radiologic healing, reduced pain and improved functional outcome vs. placebo over 3 months in pelvic fracture patients. Methods: This randomized-placebo-controlled study enrolled 35 patients (women and men ≥50 years old) within 4 weeks of pelvic fracture and evaluated the effect of blinded TPTD versus placebo over 3 months on fracture healing. Fracture healing from CT images at 0 and 3 months was assessed as cortical bridging using a 5-point scale. The numeric rating scale (NRS) for pain was administered monthly. Physical performance was assessed monthly by Continuous Summary Physical Performance Score (based on 4m walk speed, timed repeated chair stands, and balance) and the Timed Up and Go (TUG) test. Results: The mean age was 82 and >80% were female. The intention to treat analysis showed no group difference in cortical bridging score and 50% of fractures in TPTD-treated and 53% of fractures in placebo-treated patients were healed at 3 months, unchanged after adjustment for age, sacral fracture, and fracture displacement. Median pain score dropped significantly in both groups with no group differences. Both CSPPS and TUG improved in the teriparatide group, whereas there was no improvement in the placebo group (group difference p<0.03 for CSPPS at 2 and 3 months). Conclusion: In this small randomized, blinded study, there was no improvement in radiographic healing (CT at 3 months) or pain with TPTD vs placebo, however, there was improved physical performance in TPTD-treated subjects that was not evident in the placebo group