Two-drug treatment may reinforce, rebuild bones

SAN JOSE, Calif. – Forgot milk? Better get to know Forteo and Fosamax.

In a new study with potentially life-altering implications for millions of Americans with osteoporosis, researchers at the University of California-San Francisco have found that new bone can be formed – and then maintained – by taking a hormone for one year and a popular prescription drug for the next.

The findings, which appeared in Thursday’s New England Journal of Medicine, raise hopes that stronger bones might translate into fewer broken hips and so-called dowager’s humps, boosting the quality of life for many seniors and saving the country billions of dollars in medical costs annually.

“The goal of considerably reversing osteoporosis is realistic,” said Dr. Eric Orwoll, a professor of medicine at Oregon Health & Science University, one of the leading experts in the field, who was not involved in the study.

Scientists cautioned that the new study does not track whether the drug combination actually results in fewer bone fractures. Instead, it measured bone density in patients taking the medications in combination or alone.

But the results were positive enough that the researchers said physicians should be discussing the therapies with their patients, and patients should consider taking them.

Researchers studied 238 women in four cities. Those who took an experimental hormone similar to the FDA-approved Forteo, which builds bone, and followed it with a year of Fosamax, which prevents bone-density loss, saw the bone density in their spines increase an average of 12 percent.

But the researchers were floored by another finding: “If you use this bone-building agent which is very expensive for one year and you follow it by nothing, you seem to lose almost all the gains,” said Dennis M. Black, lead author of the study and professor of epidemiology and biostatistics at UCSF.

The findings are important because patients are not supposed to take Forteo, which can cost more than $6,000 a year, for more than two years because of concerns that long-term use could be cancerous. Doctors have been grappling with how to treat osteoporosis in patients once they stop taking the product, also known as a parathyroid hormone.

Taking Fosamax after a course of parathyroid hormone “is clearly an effective sequence,” said Dr. Felicia Cosman, clinical director of the National Osteoporosis Foundation.

Cosman, whose own study on treating osteoporosis was also in Thursday’s New England Journal of Medicine, found that Forteo can be taken in three-month stretches, with three months on the hormone and then three months on Fosamax, with similar success rates. That way, patients could take Forteo on again and off again for four years, and in theory may fare better than those who take the drugs for two years.

Both studies show “we now have a drug which really can build bone and repair bone structure,” she said. “This is going to make a very big difference to people who have very severe disease.”

Osteoporosis is a major public health threat in this country, with 10 million Americans suffering from it. An additional 18 million – 80 percent of whom are women – have low bone mass, putting them at risk for developing the disease.

It can be painful, and patients may experience back problems, loss of height, spinal deformities or bone fractures. The United States spends an estimated $14 billion on osteoporosis and fractures annually, according to the National Institutes of Health.

The condition is often referred to as the “silent disease” because bone loss occurs without symptoms. Bone density tests can help screen for problems, but many people do not seek them out.