Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures.
Animal experiments show a dramatic improvement in skeletal repair by teriparatide. We tested the hypothesis that recombinant teriparatide, at the 20 microg 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 microg (n = 34) or teriparatide 40 microg (n = 34) within 10 days of fracture. Hypotheses were tested sequentially, beginning with the teriparatide 40 microg 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 microg and 40 microg, respectively (overall p = .015). There was no significant difference between the teriparatide 40 microg versus placebo groups (p = .523). In post hoc analyses, there was no significant difference between teriparatide 40 microg versus 20 microg (p = .053); however, the time to healing was shorter in teriparatide 20 microg than placebo (p = .006). The primary hypothesis that teriparatide 40 microg would shorten the time to cortical bridging was not supported. The shortened time to healing for teriparatide 20 microg 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.
Aspenberg
Per
P
Orthopaedics, Linköping University, Linköping, Sweden. per.aspenberg@inr.liu.se
Genant
Harry K
HK
Johansson
Torsten
T
Nino
Antonio J
AJ
See
Kyoungah
K
Krohn
Kelly
K
García-Hernández
Pedro A
PA
Recknor
Christopher P
CP
Einhorn
Thomas A
TA
Dalsky
Gail P
GP
Mitlak
Bruce H
BH
Fierlinger
Anke
A
Lakshmanan
Mark C
MC
D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D017102:Fracture Healing / Q000187:drug effects; D050723:Fractures, Bone / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy; D011885:Radius Fractures / Q000188:drug therapy / Q000209:etiology; D019379:Teriparatide / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D019379:Teriparatide