Osteoporosis treatable with one medicine Two-year study could keep patients from wasting money

BANGOR – If one medication works to keep aging bones strong and healthy, will two do the job better? The answer, unfortunately, seems to be no, but the medical and research communities here are celebrating anyway.

Halfway into a two-year national study, researcher Clifford Rosen, M.D., of the Maine Center for Osteoporosis Research and Education at St. Joseph Healthcare has released the initial findings. The results of the study were reported in the Sept. 25 issue of the New England Journal of Medicine.

Although the study disproves his hypothesis, Rosen said at a Thursday press conference at the St. Joseph Healthcare Park that it has “tremendous economic implications” for the treatment of osteoporosis. It also supports the practice of “evidence-based” medicine, which relies on current research data rather than custom or intuition for making medical decisions, Rosen said.

Osteoporosis, a disease that affects 25 million women in America, is characterized by a loss of calcium from bones into the bloodstream, leaving the bones brittle and easily broken. Most commonly seen in post-menopausal women, osteoporosis also can affect younger women as well as men.

Funded with a $3.5 million grant from the National Institutes of Health, Rosen and his research partner Dennis Black of the University of California at San Francisco are studying two approved treatments for the crippling disorder.

Alendronate, which goes by the trade name Fosamax, has been in use for more than a decade. It comes in tablet form and generally is taken once a day. It works by inhibiting the loss of calcium from bones, and has been proved to improve bone density and reduce the risk of fracture.

Parathyroid hormone, or PTH, was approved by the Food and Drug Administration less than a year ago. It is administered daily as a shallow injection. It, too, has proved effective at reducing fractures and improving bone density, but, unlike Fosamax, PTH works by stimulating the growth of new bone.

Rosen said he and Black theorized that since the two agents act differently to achieve the same therapeutic effect, in combination they not only might work twice as well but even prove synergistically more powerful than that.

They recruited a total of 238 women from Bangor, Minneapolis, New York and Pittsburgh. For 12 months, some women took Fosamax and a placebo injection, some took PTH and a placebo tablet, and some took the two drugs. The researchers assessed the subjects’ bone density and strength before and after the yearlong study, using computerized scanning technology.

“We were surprised to see that the use of the two drugs didn’t make much difference,” Rosen said. “Taken alone, PTH works a little bit better than the alendronate, but taking them together is no better than taking the alendronate alone.”

This is good news for budget-watchers. PTH comes with a $7,000-a-year price tag, whereas Fosamax is only about $700.

The second phase of the study will look at the value of administering the two drugs in sequence. Women who took Fosamax for the past year will switch to PTH, and those who took PTH will switch to Fosamax.

Rosen also will be recruiting soon for a new study that will examine the effects of PTH if it is administered just once a week, instead of daily. Although it is considered very safe, Rosen said PTH is one of the least-tested medications on the market

“We think the formation of new bone can be turned on using much less PTH,” he said.

He praised the NIH for funding trials that probably would not be supported by manufacturers. “It’s unlikely they’d want to fund a study that stands to cut their sales to one-seventh of what they are now,” he said.

Rosen also used the press conference as an occasion to laud Maine’s biomedical “research rectangle” consisting of facilities in Bangor, the University of Maine, The Jackson Laboratory and Maine Medical Center in Portland.

“The message is that this kind of work can be done in Bangor, Maine. … we have bright, motivated, innovative scientists and the resources here to conduct research on a very high level,” Rosen said. “Our young people are leaving Maine because they think they can’t get jobs, but there is tremendous opportunity right here.”

On hand to congratulate Rosen for his internationally respected work in the field of osteoporosis were Sister Mary Norberta, president of St. Joseph Healthcare; Rick Waychik, director of The Jackson Laboratory; state Sen. Tom Sawyer, representatives from the offices of Maine’s congressional delegation, and many local health care, business and municipal officials.