Having too much of a good thing is something most of us can only wish for. But for physicians treating women in the post-menopausal years, an ever-increasing number of treatment options is as confusing as it is advantageous.
"We live in very interesting times," says Dr. Wulf Utian, executive director of the North American Menopause Society. "We have more and more therapeutic options available for a lot of different medical conditions…. But in my 30-plus years experience in the area of post-menopausal health I don't recall a time when there's been as much confusion regarding what women think or what they feel they should do to utilize their options. And, unfortunately, this confusion is carrying forward into the medical community to physicians and other health care providers."
This is why Utian and his colleagues across the continent are excited about a new clinical drug trial, by pharmaceutical manufacturer Eli Lilly and Company, designed to provided some clarity among leading treatment options for osteoporosis, a degenerative bone disease, leading to serious fractures, which affects 1.4 million Canadians and one in four women over 50.
The EVA (EVista Alendronate Comparison) trial isn't investigating a new therapy. It's a head-to-head comparison of two approved medications – Evista and Fosamax – that have been proven effective in treating osteoporosis.
Evista (raloxifene), an Eli Lilly drug, is a selective estrogen receptor modulator, an estrogen-like drug which exerts a positive effect on the bones and heart, but seems to have no adverse effect on the uterus or breast. Fosamax (alendronate sodium), manufactured by Merck and Company, is one of a class of drugs called bisphsphonates, which bind permanently to the bone surfaces and slow down erosion that occurs naturally as bones replenish themselves to remain strong. Because Fosamax works only the bone, it has few side effects and has been preferred by women who are unwilling or unable to take hormone and related therapies.
The EVA trial will compare the ability of the drugs to reduce osteoporotic fractures in 3,000 post-menopausal women between 50 and 80 years who have been diagnosed with osteoporosis. It will be carried out at approximately 150 sites in Canada, the United States and Puerto Rico and will involve about 20 Canadian investigators.
Secondary objectives of the trial will examine the specific sites of fractures – such as spine, hip or wrist – and the incidence of newly diagnosed breast cancer along with other safety-related issues.
Utian says this trial is important because it compares two drugs that have been well studied individually in a direct head-to-head manner and because it is looking at "true outcome data" in studying fracture rates as opposed to intermediate markers such as bone mineral density.
As well, he says, since there is no placebo control group the ethical issue of placing a patient with osteoporosis on a non-active treatment for five years does not apply. "Both groups will be getting an active anti-osteoporotic drug."
Physicians have many issues to consider in prescribing drugs and must carefully weigh all pros and cons, Utian says. "A study such as EVA allows the elucidation of some of the other effects (such as the possibility of breast cancer) so that the ultimate decision regarding the most appropriate course of therapy can be individualized to the patient."
Dr. Leo Plouffe Jr., U.S. medical director for women's health with Eli Lilly, points out that EVA is also significant in that it will be the first large-scale osteoporosis study to place emphasis on recruiting African American and Hispanic women as well as Caucasians. "We feel this is important because, overall, minority women have been under-represented in osteoporosis studies," he says.
Recruitment of study participants will begin next month and early results of the five-year trial will be available in 2006. Those interested in learning more about EVA may call toll-free 888-545-5972.