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Significant Increases in Bone Mineral Density With Alendronate Over Raloxifene in Head-To-Head Study: Presented at ASBMR

By Mary Beth Nierengarten

MINNEAPOLIS, MN -- October 6, 2003 -- In the first head-to-study comparing a weekly dosage of alendronate with a daily dosage of raloxifene for postmenopausal women with osteoporosis, alendronate produced significantly greater increases in bone mineral density (BMD) in the spine and hip.

A. E. de Papp, MD, of Merck & Co., West Point, Pennsylvania, United States, presented the findings here September 21^st at the 25^th Annual Meeting of the American Society for Bone and Mineral Research .

Based on previous clinical data of the efficacy of alendronate, Dr. de Papp not surprised by the outcome. "We could have predicted that alendronate would be associated with better bone mineral density," she said, adding that the study also highlights the stronger comparative effect on markers of bone density. "Two key points of this study [are] that alendronate was associated with twice as much BMD and twice the suppression of bone turnover markers," she said.

In a multicenter study of 456 postmenopausal women from 52 centres in the United States, 223 were randomised to receive alendronate 70 mg once weekly, and 233 to receive raloxifene 60 mg daily. Women were included in the study if they were 40 or older (or 25 and older if surgically menopausal) and postmenopausal for at least six months, and if they had osteoporosis as defined as a BMD of 2.0 or more below young normal mean bone mass for either total hip or lumbar spine. Baseline characteristics between the two groups were comparable in terms of age, years since menopause, race, BMD and T-score for the lumbar spine and hip.

At 12 months, patients treated with alendronate, compared with patients taking raloxifene, had about twice the increase in lumbar spine BMD (4.4% vs. 1.9%, respectively), total hip BMD (2.0% vs. 1.0%, respectively), and hip trochanter BMD (3.2% vs. 1.8%, respectively). Compared with the increases reported at six months, these 12 month increases were all statistically significant.

In addition, use of alendronate was associated with greater decreases in urine n-telopeptide (NTx) and bone-specific alkaline phosphatase (BSAP), two bone turnover markers, at both six and 12 months, compared with use of raloxifene.

A perhaps surprising outcome of the study, said de Papp, is the comparable tolerability of the drugs. "People thought that more adverse effects, particularly of the upper [gastrointestinal] GI tract, would be found in the alendronate group," she said. "But we found no difference in adverse effects between the two groups."

Although the study looked at fracture risk as an adverse event, it was not designed to evaluate the comparative effect of these two drugs on fractures and did not have the power to do so, said de Papp.


[Study title: Efficacy of Fosamax vs Evista Comparison Trial (EFFECT): Results of a Randomized, Multicenter Study. Abstract SU343]

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