Fosamax Scare: Those With Osteopenia Gauge Risk

March 10, 2010— -- Twice doctors have prescribed medications for Jeanette McLearen with great certainty, only to second-guess the outcomes.

After taking hormone replacement for 15 years, the Warren, Mich., retiree was diagnosed with breast cancer. And now, after seven years of taking the controversial drug Fosamax, she is terrified of bone fractures.

Just this week ABC's Dr. Richard Besser reported that Fosamax, one of a class of bisphosphonates used to treat osteoporosis that is supposed to make bones stronger, may actually weaken them after long-term use.

The U.S. Food and Drug Administration announced today that it will look into whether or not a link exists between the use of certain osteoporosis drugs and a particular type of leg fracture after ABC News reports investigated the possible connection.

In numerous cases of women who had taken the drug for long periods of time, their femur bones had just snapped while doing little more than taking a walk.

"We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise," said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. "Very unusual, the femur is one of the strongest bones in the body."

Now, at 66, McLearen said her doctor wants her to have further injections for bone loss, but she cancelled her first appointment this week.

"I am scared and I am confused," she said. "I don't know what I think. I don't know what to do."

McLearen, like millions of post-menopausal women, was treated with bisphosphonates for osteopenia, a term used to describe bone mineral density that is lower than normal, but not yet osteoporotic.

The controversy is reminiscent of the medical world's turn-about on use of hormone replacement therapy in 2002. Thought to reduce women's risk of heart disease, combined estrogen and progestin actually increased risks for both that and for breast cancer.

"This is two things for me now, hormone treatment and now this," McLearen said. "They put me on Fosamax thinking it was one thing, and years go by, and they find out it's wrong."

Like osteoporosis, osteopenia occurs more frequently in post-menopausal women as a result of the loss of estrogen. It may affect more than 17 million American women, according to some studies.

Bisphosphonates like Fosamax -- which is also now sold as generic alendronate -- and its pharmaceutical cousins Actonel, Boniva and others, were developed in the mid-1990s to treat osteoporosis, but have been increasingly prescribed for osteopenia.

Doctors use a so-called T-score to determine the amount of bone loss that naturally occurs with aging. A mineral bone density score of -1.5 to -2.5 is considered osteopenia. Over -2.5 is osteroporosis, according to the World Health Organization.

T-scores are measured by bone density machines, known as DXA or dual X-ray absorptiometry.

Though osteopenia is considered a precursor to osteoporosis, not every person diagnosed will go on to develop the disease.

This is not the first time that doctors have reported an opposite effect for Fosamax. The drug, made by Merck & Co., has already been linked to severe musculoskeletal pain, as well as to a serious bone-related jaw disease called osteonecrosis.

After taking Fosamax for eight years, Stephanie George said she was advised not to have dental surgery for an absess on her wisdom tooth until she had been off the drug for five years.

"They said there was a rare, but real chance that my bottom jaw would become infected and might have to be removed," said George, a 67-year-old retired college teacher from Frisco, Texas.