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TUESDAY, Jan. 27 (HealthDayNews) -- European investigators have found that a drug that had been shelved for years decreases the risk of vertebral fractures in women with osteoporosis.

If approved in the United States, strontium ranelate could become another weapon in the fight against a disease that is estimated to affect 10 million Americans.

"I think it would be a very important drug," says Dr. Stephen Honig, director of the Osteoporosis Center at the Hospital for Joint Diseases in New York City. "It would be a competing drug, just like there are different kinds of blood pressure pills."

The findings appear in the Jan. 29 issue of the New England Journal of Medicine.

Strontium ranelate already has a long and somewhat checkered history.

According to an editorial appearing in the same issue of the journal, strontium was originally found in lead mines in Scotland in the late 18th century. It was used in the 1950s to manage osteoporosis and, more recently, one form of it was used for cancer of the bone. It was shelved because it appeared to interfere with the synthesis of vitamin D. It is now thought that that effect might have been due to calcium-poor diets and to dosing. As a result, there has been a renewed interest.

Excitement about strontium ranelate spurred four clinical trials in the 1990s and now this one, which was supported by Servier, the French pharmaceutical giant that developed the drug. Many of the study's authors have received consulting fees, lecturing fees or grants from Servier and other drug companies.

The trial, which took place at 72 centers in 11 European countries and Australia, involved 1,649 postmenopausal women with osteoporosis who had had at least one vertebral fracture. The women were randomly assigned to receive 2 grams of the drug each day or a placebo. The women were also given vitamin D and calcium supplements.

By the end of the first year, women in the intervention arm had 49 percent fewer vertebral fractures than women in the placebo arm. At the end of the three years, women in the strontium ranelate group had 41 percent fewer vertebral fractures than women in the placebo group. According to the study, nine patients would need to be treated for three years to prevent one patient from having a vertebral fracture.

At the three-year mark, strontium ranelate had increased bone mineral density, an indicator of osteoporosis, by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck.

Withdrawal from the study due to side effects was similar in each group.

All of the benefit was seen in the vertebra. "They haven't shown any improvement at the hip, and the hip is the most important in terms of morbidity and mortality of osteoporosis," says Dr. Loren Wissner Greene, an endocrinologist with New York University Medical Center and clinical associate professor of medicine at New York University School of Medicine in New York City. "It is surmised from this article that it will probably be helpful for the hip, but in order to do hip studies, you usually have to do a larger study. There might not be enough women in this study to show a hip effect."

According to the study authors, the reductions noted here are similar to those reported by other osteoporosis drugs including alendronate (47 percent), risedronate (49 percent), raloxifene (30 percent), and parathyroid hormone (65 percent after 21 months of treatment).

Parathyroid hormone, however, has a black-box warning because it increased the risk of a certain type of cancer in mice. It is also available for use for only 18 to 24 months because of this possible danger and is available only by injection, Greene points out.

Unlike the existing armamentarium, however, strontium ranelate seems to promote new bone formation. "This is the first drug that I'm aware of which interferes at least initially with bone resorption. . . and also promotes bone formation," Honig says.

More information

For more on osteoporosis, visit the National Institutes of Health or the National Osteoporosis Foundation.

(SOURCES: Loren Wissner Greene, M.D., endocrinologist, New York University Medical Center, and clinical associate professor, medicine, New York University School of Medicine, New York City; Stephen Honig, M.D., director, Osteoporosis Center, Hospital for Joint Diseases, New York City; Jan. 29, 2004, New England Journal of Medicine)

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