The Journal of Bone and Joint Surgery (American). 2009;91:1329-1338.
doi:10.2106/JBJS.H.01030
© 2009 The Journal of Bone and Joint Surgery, Inc.
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Teriparatide and Raloxifene Reduce the Risk of New Adjacent Vertebral Fractures in Postmenopausal Women with Osteoporosis

Results from Two Randomized Controlled Trials

Mary L. Bouxsein, PhD1, Peiqi Chen, PhD2, Emmett V. Glass, PhD2, David F. Kallmes, MD3, Pierre D. Delmas, MD, PhD4 and Bruce H. Mitlak, MD2

1 Orthopedic Biomechanics Laboratory, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, RN 115, Boston, MA 02215. E-mail address: mbouxsei{at}bidmc.harvard.edu
2 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285
3 Department of Radiology, Mayo Clinic, 200 First Street S.W., Rochester, MN 55905
4 University of Lyon and INSERM Research Unit 831, Hôpital Edouard Herriot, 69437 Lyon CEDEX 03, France

Investigation performed at Eli Lilly and Company, Indianapolis, Indiana

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. One or more of the authors, or a member of his or her immediate family, received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Eli Lilly). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Background: Vertebral fractures increase the risk of new vertebral fractures; however, we are not aware of any study addressing the risk of new vertebral fractures adjacent to existing vertebral fractures. Therefore, we sought to determine the influence of the number and severity of prevalent (preexisting) vertebral fractures on the risk of new adjacent vertebral fractures and to determine whether teriparatide (rhPTH [recombinant human parathyroid hormone] [1-34]) or raloxifene treatment reduces the incidence of adjacent vertebral fractures in postmenopausal women with osteoporosis.

Methods: Data from the Fracture Prevention Trial and the Multiple Outcomes of Raloxifene Evaluation trial were analyzed to determine the incidences of new adjacent and new nonadjacent vertebral fractures in the placebo groups and the effect of treatment with raloxifene and teriparatide on the incidence of new adjacent vertebral fractures as compared with that of new nonadjacent vertebral fractures.

Results: Of 1226 untreated postmenopausal women with one or more prevalent vertebral fractures at baseline, 196 (16.0%) had a total of 292 new vertebral fractures during the two-year follow-up period, with 108 (8.8%) of the 1226 women having at least one new fracture adjacent to a prevalent fracture. Of the 292 new vertebral fractures, 136 (47%) were adjacent to a previously existing vertebral fracture. The risk of a new adjacent vertebral fracture was 2.5-fold higher than the risk of a new nonadjacent vertebral fracture (4.03% compared with 1.59%). The incidence of new adjacent vertebral fractures increased with both the number and the severity of prevalent vertebral fractures. Teriparatide reduced the risk of any new, new adjacent, and new nonadjacent vertebral fractures by 72%, 75%, and 70%, respectively, compared with the rates in the placebo group. Similarly, compared with the placebo, raloxifene treatment reduced the risk of any new vertebral fracture, new adjacent vertebral fracture, and new nonadjacent vertebral fracture by 54%, 54%, and 53%, respectively.

Conclusions: In untreated postmenopausal women with osteoporosis, nearly half of the incident vertebral fractures occur adjacent to an existing vertebral fracture. Both teriparatide and raloxifene can significantly reduce the occurrence of new adjacent and nonadjacent vertebral fractures.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.


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