Longterm Reduction of Back Pain Risk in Women with Osteoporosis Treated with Teriparatide Compared with Alendronate

PAUL D. MILLER, WILLIAM J. SHERGY, JEAN-JACQUES BODY, PEIQI CHEN, MARK E. ROHE, and JOHN H. KREGE

ABSTRACT.

Objective. To compare the effects on back pain of teriparatide versus alendronate, we analyzed the reporting of back pain in a head to head comparator trial and a followup study.

Methods. In the comparator trial, women were randomized to receive either daily self-injected teriparatide 40 µg plus an oral placebo (n = 73), or daily oral alendronate 10 mg plus self-injected placebo (n = 73). Treatment was for a median 14 months. After completion of the comparator trial, 72% of these patients enrolled in a nontreatment followup study. Adverse events were recorded at each comparator trial visit and followup study visit, and the incidence of new or worsening back pain in each group was compared.

Results. During the comparator trial, compared with women randomized to alendronate 10 mg, women randomized to teriparatide 40 µg had reduced risk for any back pain (relative risk 0.27, 95% CI 0.09–0.82) and moderate or severe back pain (relative risk 0.19, 95% CI 0.04–0.86). The differences in the reporting of back pain between the teriparatide treated women and the alendronate treated women were sustained during an interval including the comparator trial plus 18 additional months. During an interval including the comparator trial plus 30 additional months, teriparatide treated patients had numerically fewer occurrences of back pain and moderate or severe back pain.

Conclusion. Compared with women randomized to alendronate 10 mg, women randomized to teriparatide 40 µg had reduced risk of back pain during the trial and 2.5 years of followup. (J Rheumatol 2005;32:1556-62)

Key Indexing Terms:

BACK PAIN
OSTEOPOROSIS
BONE FORMATION
TERIPARATIDE
ALENDRONATE

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From the Colorado Center for Bone Research, Lakewood, Colorado; Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, Indiana; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; and Rheumatology Associates of North Alabama, Huntsville, Alabama, USA.

Supported by Eli Lilly and Company.

P.D. Miller, MD, Medical Director, Colorado Center for Bone Research, and University of Colorado Health Sciences Center, Denver; W.J. Shergy, MD, Rheumatology Associates of North Alabama; J.J. Body, MD, PhD, Institut Jules Bordet, Université Libre de Bruxelles; P. Chen, PhD, Research Scientist, Lilly Research Laboratories; M.E. Rohe, PhD, Senior Scientific Communications Associate, Lilly Research Laboratories; J.H. Krege, MD, Medical Advisor, Lilly Research Laboratories.

Address reprint requests to Dr. P.D. Miller, Colorado Center for Bone Research, 3190 S. Wadsworth Boulevard, Suite 250, Lakewood, CO 80227. E-mail: millerccbr@aol.com

Accepted for publication March 9, 2005.

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