Original Article

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

Per Aspenberg 1 *, Harry K Genant 2 3, Torsten Johansson 1, Antonio J Nino 4, Kyoungah See 4, Kelly Krohn 4, Pedro A García-Hernández 5, Christopher P Recknor 6, Thomas A Einhorn 7, Gail P Dalsky 4, Bruce H Mitlak 4, Anke Fierlinger 3, Mark C Lakshmanan 4

1Orthopaedics, Linköping University, Linköping, Sweden 2University of California-San Francisco, San Francisco, CA, USA 3Synarc, Inc., San Francisco, CA, USA 4Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA 5Depto de Endocrinología, Centro de Osteoporosis, Hospital Universitario de Nuevo León, Monterrey, Mexico 6United Osteoporosis Centers, Gainesville, GA, USA 7Boston University Medical Center, Boston, MA, USA

email: Per Aspenberg (per.aspenberg@inr.liu.se)

^*Correspondence to Per Aspenberg, Section for Orthopaedics, IKE Faculty of Health Sciences, Linköping University, Linköping, Sweden 581 85.

Data included in this manuscript were presented in part at the 35th ECTS Congress, Barcelona, Spain, 24-28 May 2008. Abstract publication: Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia P, Recknor CP, Einhorn TA, Dalsky GP, Lakshmanan M. Effects of teriparatide on distal radial fracture healing in postmenopausal women: a randomized double-blinded study [abstract no. Su-P417]. Calcif Tissue Int. 2008;82:S218.

Keywords

Colles' fracture • cortical bridging • distal radial fracture • fracture healing • teriparatide

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 µg (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 40 µg, 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 µg 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

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Received: 2 December 2008; Revised: 18 May 2009; Accepted: 8 July 2009

Digital Object Identifier (DOI)

10.1359/jbmr.090731  About DOI