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Alendronate May Offer Better Improvements in Bone Mineral Density and Bone Turnover Than Raloxifene

Improvements in bone mineral density (BMD) and bone turnover markers are significantly greater during treatment with alendronate 70 mg once weekly compared to raloxifene 60 mg daily in postmenopausal women with low bone density, while the two regimens have similar tolerability.

Both alendronate and raloxifene inhibit bone resorption, but have differing mechanisms of action. Evidence suggests that raloxifene may not reduce nonvertebral or hip fractures as effectively as alendronate.

To compare the efficacy and tolerability of the agents, Philip N. Sambrook, MD, University of Sydney, Sydney, Australia, and colleagues performed a randomised, double-masked, double-dummy, multicentre, international study that enrolled 487 postmenopausal women with low bone density.

Over a 12-months period, 246 patients received alendronate (Fosamax) 70 mg once weekly and daily placebo and 241 received raloxifene (Evista) 60 mg daily and weekly placebo.

Measurements were taken at 6 and 12 months in BMD of the posterior-anterior lumbar spine and total hip, bone turnover markers. Adverse events were recorded at randomisation and at 3, 6 and 12 months.

Results showed substantial differences between treatments within 6 months that continued until study end. BMD increases were significantly greater at the lumbar spine and total hip with alendronate (4.8% and 2.3%, respectively, P < .001) than with raloxifene (2.2% and 0.8%, respectively, P < .001).

Similarly, improvements were significantly greater with alendronate in serum bone-specific alkaline phosphatase and urinary N-telopeptide of type I collagen (P < .001 for both).

Tolerability was similar with the 2 treatments, but significantly more patients treated with raloxifene reported vasomotor events (P = .010).

"Although greater reduction in bone turnover was seen with alendronate than with raloxifene, the optimal change in markers of bone turnover to achieve the greatest reduction in fracture risk is not known and this is an area which requires further investigation," the researchers said.



J Intern Med 2004 Apr;255:4:503-11. "Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density: results of EFFECT (EFficacy of FOSAMAX versus EVISTAComparison Trial) International"

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