Though Fosamax, the drug that is widely advertised to women, has been on the market for eight years, there are several lingering questions. How long can women safely take this drug? If Fosamax is stopped, will its bone protection benefits disappear? Should it be prescribed to middle-aged women with minimal bone loss?
The most serious concern was raised by some researchers who worry that many years of using Fosamax (or another drug like Actonel in a class called bisphosphonates) could eventually cause more fractures. Bones are constantly being remodeled, breaking down old bone and growing newer healthier bone. Bisphosphonates, however, slows this turnover, which could become counterproductive. By stopping the resorption of the old bone, the drug could prevent its replacement by new bone, thus making the bone more brittle and prone to fracture. With so many unknowns, the more cautious doctors do not prescribe bisphosphonates to women in their 50s. Until there is proof that these drugs are effective at preventing a hip fracture 20 years in the future, this seems like a safe decision because hip fractures are not likely to occur before the age of 70.
Last month, some of the information gaps surrounding Fosamax use were filled in by a pooled analysis of two clinical trials. It was entitled "Ten Years' Experience with Alendronate [Fosamax] in Postmenopausal Women" (New England Journal of Medicine, 3/18/04). Together, the trials involved nearly 1,000 women with osteoporosis, one-third of whom had spinal fractures before entering the studies. They had been randomly assigned to take either Fosamax or a placebo, and the average age at enrollment was 63. The research team led by Henry G. Bone, MD, concluded, "The therapeutic effects of alendronate [Fosamax] were sustained and well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects."
But most women take Fosamax to avoid a hip fracture, which has the most serious complications. Unfortunately, the new analysis did not address this issue. Thousands more study participants would have been needed to prove fracture prevention, wrote Dr. Bone in a letter to the New York Times.
COPYRIGHT 2004 Center for Medical Consumers, Inc.
COPYRIGHT 2004 Gale Group