For post-menopausal women, potential cancer-causing side effects from estrogen treatments that prevent osteoporosis and heart disease could be worse than the illnesses themselves.
But a new drug being tested by University medical researchers may be the solution to the treatment benefit/side-effect paradox.
The drug, called Tibilone, could provide the benefits that current treatments give to post-menopausal women without the risk of causing cancer.
Stephen Glasser, lead investigator and professor of epidemiology, said research has found that older women become increasingly susceptible to osteoporosis, or the decline in density of the bones, after menopause. Women are also at higher risk for cardiovascular difficulties.
Menopause occurs in most women between ages 35 and 60, during which hormone production, ovulation and menstruation slow down and eventually cease. During that time, levels of the female sex hormone estrogen decline in the body.
Researchers believe estrogen is an important factor in maintaining bone density and moderating cholesterol levels — a leading cause of heart disease — in premenopausal women.
Heart disease is the leading cause of death among American women, claiming almost 500,000 women’s lives annually.
Conventional treatment entails administering estrogen or a combination of estrogen and another female sex hormone, progesterone.
Though believed to be beneficial, patients receiving the treatment experienced higher rates of developing cancer.
“The problem is the balance between the risk versus the benefit,” Glasser said.
The new drug was designed to avoid estrogen’s pitfalls and lower the danger to women.
Russell Luepker, head of the division of epidemiology, said all women might face this problem someday.
“All older women are menopausal,” Luepker said. “Because so many women are taking estrogen now, there’s a vast need for this.”
Tibilone is part of a new class of drugs. Called selective estrogen receptor modifiers, they are designed to maintain the benefits of estrogen but limit side effects.
Designed almost five years ago, Tibilone has been available in Europe for several years. The success of the University’s study could pave the way for approval in the United States.
“If this new class of drugs proves to be beneficial in preventing both osteoporosis and reducing the cardiovascular risk,” Glasser said, “obviously more women can benefit.”
The study will follow 80 to 100 women for three years. Throughout the study, while some of the women will be given the Tibilone, others will get a combination of progesterone and estrogen or a placebo. The researchers will then periodically test the women’s bone density and cardiovascular condition.
Cathy Bell, director of the University’s Osteoporosis Research Clinic, is currently recruiting patients to participate.
Bell said potential candidates must pass a thorough series of tests before they can enroll. Candidates must be in good health and must not suffer from high levels of bone depletion.
So far, three candidates have been chosen for the study. Bell said the researchers hope to enroll 50 by the end of October.
Although the effects of menopause are inevitable, Glasser said younger women can take some steps to limit osteoporosis and cardiovascular difficulties such as increasing their calcium intake and exercising regularly.