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Comparison of Weekly Treatment of Postmenopausal Osteoporosis with Alendronate Versus Risedronate Over Two Years

Clinical Research Center of North Texas (S.B.), Denton, Texas 76210; Division of Clinical Immunology and Rheumatology (K.G.S.), University of Alabama at Birmingham, Birmingham, Alabama 35294; Beth Israel Deaconess Medical Center and Harvard Medical School (D.P.K.), Boston, Massachusetts 02215; Oregon Osteoporosis Center (M.M.), Portland, Oregon 97213; University of Maryland School of Medicine (M.H.), Baltimore, Maryland 21201; Endocrine Unit (S.-A.M.B.), Massachusetts General Hospital, Boston, Massachusetts 02114; Arthritis Associates (A.S.), Palm Harbor, Florida 34684; Foundation for Osteoporosis Research and Education (R.K.), Oakland, California 94612; and Merck & Co., Inc. (E.C. D.E.T., A.E.d.P.), West Point, Pennsylvania 19486

Address all correspondence and requests for reprints to: Dr. Sydney Bonnick, Clinical Research Center of North Texas, 2921 Country Club Road, Suite 101, Denton, Texas 76210. E-mail: sbonnick{at}msn.com.

Objective: A 1-yr extension of the Fosamax Actonel Comparison Trial was completed to compare changes in bone mineral density (BMD), bone turnover, and upper gastrointestinal tolerability over 2 yr of treatment.

Design: This was a randomized, double-blind extension conducted at 72 U.S. sites.

Patients and Methods: Of the 1053 women who completed yr 1, 833 postmenopausal women with low BMD entered the extension, continuing their same treatment allocation [once-weekly (OW) alendronate 70 mg or OW risedronate 35 mg]. Changes in BMD at the hip trochanter, total hip, femoral neck, and lumbar spine and in markers of bone turnover were compared at 24 months. Tolerability was assessed by adverse experience reporting.

Results: Alendronate produced greater increases from baseline in BMD at 24 months than did risedronate at the trochanter (alendronate, 4.6%; risedronate, 2.5%, P < 0.001) as well as at all other BMD sites. Significantly more alendronate than risedronate patients had measured BMD increases of 0% or more and 3% or more at all BMD sites (P < 0.001), and fewer alendronate patients had measured decreases of 3% or more at all BMD sites. Significantly greater reductions in all biochemical markers of bone turnover occurred with alendronate, compared with risedronate. No differences were seen in occurrence or discontinuations due to upper gastrointestinal adverse experiences.

Conclusions: Patients receiving 70 mg OW alendronate had greater gains in BMD, were more likely to maintain or gain BMD, and had greater reductions in bone turnover markers than patients receiving 35 mg OW risedronate after 24 months, with no differences in upper gastrointestinal tolerability.

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