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Submitted on November 30, 2005
Accepted on April 18, 2006
Clinical Research Center of North Texas, Denton, TX; Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; Oregon Osteoporosis Center, Portland, OR; University of Maryland School of Medicine, Baltimore, MD; Massachusetts General Hospital, Endocrine Unit, Boston, MA; Arthritis Associates, Palm Harbor, FL; Foundation for Osteoporosis Research and Education, Oakland, CA; Merck & Co., Inc., West Point, PA
* To whom correspondence should be addressed. E-mail: sbonnick{at}msn.com.
Objective: A 1-year extension of the FOSAMAX® ACTONEL® Comparison Trial (FACT) was completed to compare changes in bone mineral density (BMD), bone turnover, and upper gastrointestinal tolerability over 2 yr of treatment.
Design: Randomized, double-blind extension conducted at 72 US sites.
Patients and Methods: Of the 1053 women who completed Year 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 (ALN, 4.6%; RIS, 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% and
3% at all BMD sites (P < 0.001), and fewer alendronate patients had measured decreases of
3% 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 OW alendronate 70 mg had greater gains in BMD, were more likely to maintain or gain BMD, and had greater reductions in bone turnover markers than patients receiving OW risedronate 35 mg after 24 months, with no differences in upper gastrointestinal tolerability.
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