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Alendronate Superior to Raloxifene in Increasing Bone Mineral Density: Presented at NAMS

By Deanna M Green, PhD

MIAMI, FL -- October 7, 2003 -- Alendronate treatment resulted in greater increases in bone mineral density (BMD) and similar adverse events as raloxifene in a head-to-head clinical trial in postmenopausal women, according to findings presented here September 19^th at the 14^th Annual Meeting of The North American Menopause Society.

A growing number of preventative and treatment prescription medications are available for postmenopausal women with osteoporosis, each with its own advantages and disadvantages. For physicians to choose the best treatment possible, it is necessary to compare various treatments within the same trial, where efficacy and safety are measured in parallel.

Risa Kagan, MD, Foundation for Osteoporosis Research and Education, Oakland, California, United States, and colleagues conducted a head-to-head clinical trial to evaluate the safety and efficacy of two common treatments for osteoporosis in postmenopausal women -- the bisphosphonate drug alendronate and the selective oestrogen receptor modulator (SERM) drug raloxifene.

The study included two trials, one based in the United States that consisted of 456 postmenopausal women with a mean age of 64 years and one conducted in more than 16 countries that enrolled 487 postmenopausal women with a mean age of 62 years.

Participants were given calcium and vitamin D supplementation and were randomised to receive alendronate 70 mg once weekly and daily placebo or raloxifene 60 mg daily and weekly placebo. Bone mineral density (BMD) and markers of bone turnover, namely urine n-telopeptide [NTx] and bone-specific alkaline phosphatase [BSAP] were measured at 3, 6, and 12 months of treatment.

Patients receiving alendronate had a 2-3 fold greater increase in BMD of the hip, spine, and trochanter than those given raloxifene. Specifically, a 4.4% increase in lumbar spine BMD was seen with alendronate at 12 months, compared to a 1.9% increase with raloxifene (P<0.001). The superiority of alendronate was apparent at 6 months and increased with 12 months of treatment, and was also evident in the reduction of markers for bone turnover.

Significantly more patients responded to alendronate treatment than raloxifene treatment, with 66% of patients receiving alendronate showing a 3% or greater improvement in lumbar spine BMD compared to 38% of those given raloxifene.

Overall, alendronate and raloxifene showed similar degrees of tolerability, though more patients reported vasomotor symptoms with raloxifene treatment. Dr. Kagan noted, "No significant differences were seen in the percent of patients who experienced upper gastrointestinal adverse events."

Dr. Kagan concluded from this study, "Alendronate provides greater increases in BMD and greater reduction of bone resorption than does raloxifene." She added, "These results are important for physicians to consider when evaluating treatment options for postmenopausal women with osteoporosis."

This study was supported by Merck & Company, Inc., West Point, Pennsylvania, United States.


[Study title: Comparison of Alendronate and Raloxifene for Treatment of Postmenopausal Osteoporosis: Results from EFFECT and EFFECT-International. Poster-110.]

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