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Previous Volume 350:1189-1199 March 18, 2004 Number 12 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Perspective by Strewler, G. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years.

Methods The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study.

Results Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit.

Conclusions The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects.

Source Information

From Michigan Bone and Mineral Clinic, Detroit (H.G.B.); Medical Research Center, Nottingham City Hospital, Nottingham, United Kingdom (D.H.); Saint-Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium (J.-P.D.); Department of Medicine, Roger Williams General Hospital, Providence, R.I. (J.R.T.); Radiant Research–Reading, Wyomissing, Pa. (R.D.E.); Good Health Associates in Adult Medicine, South Burlington, Vt. (R.P.T.); Departamento de Endocrinologia, Escuela de Medicina, Universidad Catolica de Chile, Santiago, Chile (J.A.R.-P.); Virginia Commonwealth University, Richmond (R.W.D.); Merck Research Laboratories, Rahway, N.J. (J.G., A.C.S.); and Felsenstein Medical Research Center, Sackler Faculty of Medicine, Tel Aviv University, Petah-Tikva, Israel (U.A.L.).

Address reprint requests to Dr. Bone at the Michigan Bone and Mineral Clinic, 22201 Moross Rd., Suite 260, Detroit, MI 48236.

Full Text of this Article

Related Letters:

Ten Years of Alendronate Treatment for Osteoporosis in Postmenopausal Women
Bjarnason N. H., Chan A. S., Ott S. M., Ruggiero S. L., Mehrotra B., Bone H. G., Santora A. C.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:190-192, Jul 8, 2004. Correspondence

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