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A Randomized Double-Blind Trial to Compare the Efficacy of Teriparatide [Recombinant Human Parathyroid Hormone (1–34)] with Alendronate in Postmenopausal Women with Osteoporosis

Department of Medicine (J.-J.B.), Institut J. Bordet, Université Libre de Bruxelles, 1000 Brussels, Belgium; Lilly Research Laboratories (G.A.G., W.H.S., P.M.K.), Eli Lilly and Co., Indianapolis, Indiana 46285; Colorado Center for Bone Research (P.D.M.), Lakewood, Colorado 80227; Centre Hospitalier Universitaire Brugmann (A.Pe.), Rheumatology Clinic, 1020 Brussels, Belgium; (R.K.D.), Anaheim, California 92801; Department of Nephrology and Mineral Metabolism (R.C.-R.), Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubiran, 14000 Mexico DF, Mexico; Department of Medicine (A.Pa.), Hamilton Health Sciences, McMaster University, Hamilton, L8N 3Z5 Ontario, Canada; Department of Obstetrics and Gynecology (D.C.C.), Royal Alexandra Hospital, University of Alberta, Edmonton, T5H 3V9 Alberta, Canada; and Department of Medicine (A.B.H.), St. Joseph’s Health Care Center London and Lawson Health Research Institute, University of Western Ontario, London, N6A 4V2 Ontario, Canada

Address all correspondence to: Prof. J. J. Body, Institut J. Bordet, 1, rue Héger-Bordet, 1000 Bruxelles, Belgium. E-mail: jj.body{at}bordet.be. Address requests for reprints to: Gregory A. Gaich, M.D., Lilly Research Laboratories, Eli Lilly and Co., Lilly Corporate Center, Indianapolis, Indiana 46285.

Abstract

Teriparatide (rDNA origin) injection [recombinant human PTH (1–34)] stimulates bone formation, increases bone mineral density (BMD), and restores bone architecture and integrity. In contrast, bisphosphonates reduce bone resorption and increase BMD. We compared the effects of teriparatide and alendronate sodium on BMD, nonvertebral fracture incidence, and bone turnover in 146 postmenopausal women with osteoporosis. Women were randomized to either once-daily sc injections of teriparatide 40 µg plus oral placebo (n = 73) or oral alendronate 10 mg plus placebo injection (n = 73). Median duration of treatment was 14 months. At 3 months, teriparatide increased lumbar spine BMD significantly more than did alendronate (P < 0.001). Lumbar spine-BMD increased by 12.2% in the teriparatide group and 5.6% in the alendronate group (P < 0.001 teriparatide vs. alendronate). Teriparatide increased femoral neck BMD and total body bone mineral significantly more than did alendronate, but BMD at the one third distal radius decreased, compared with alendronate (P 0.05). Nonvertebral fracture incidence was significantly lower in the teriparatide group than in the alendronate group (P < 0.05). Both treatments were well tolerated despite transient mild asymptomatic hypercalcemia with teriparatide treatment. In conclusion, teriparatide, a bone formation agent, increased BMD at most sites and decreased nonvertebral fractures more than alendronate.

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