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New Drug Fights Osteoporosis and Broken Bones
Jan. 28, 2004 -- A new weapon may soon be added to the growing arsenal of therapies that can help fight the damage caused by osteoporosis.
New research shows the drug strontium ranelate can cut the risk of vertebral fractures by nearly half in postmenopausal women with osteoporosis. Vertebral fractures -- or breaks in the small bones that make up the spine -- are a common and potentially disabling complication of osteoporosis.
The drug has not yet been approved for use in treating osteoporosis, but the results of a phase III clinical trial show that it can safely and effectively be used to reduce the risks of vertebral fractures in women with this bone-thinning disease.
Drug Makes Bones Stronger
An earlier phase II clinical trial of strontium ranelate showed that the drug helps build stronger bones by both increasing bone formation and reducing bone loss.
The drug is made from strontium, which is a naturally occurring earth element first discovered in Scottish lead mines in the 1700s. It's found in food and water and also in small amounts in the skeleton.
In this study, published in the Jan. 29 issue of The New England Journal of Medicine, researchers examined the effectiveness of the drug in preventing vertebral fractures in a group of 1,649 postmenopausal women with osteoporosis, all of whom already had one vertebral fracture. The study participants were women at risk for future fracture, that's because having a vertebral deformity predicts an increase risk of future vertebral fractures.
Half of the women were given 2 grams of strontium ranelate per day for three years and the others were given a placebo. All the women received daily calcium supplements of 1500 milligrams per day, and 400-800 IU of vitamin D per day.
The study showed that compared with women who took placebo pills, the women who received strontium ranelate had a 49% reduction in the risk of vertebral fractures in the first year they took the drug and a 41% reduction in risk over the course of the study.
The drug also increased bone mineral density (an indicator of bone strength) by 6.8% at the spine. There were no significant differences in the number of serious adverse events or side effects reported between the two groups.
The researchers write that the reduction in the risks of fractures of the spine, seen with strontium ranelate therapy, is similar to reductions reported with other anti-osteoporosis drugs such as Fosamax, Actonel, or parathyroid hormone.
In an editorial that accompanies the study, Ghada El-Hajj Fuleihan, MD, MPH, of the American University of Beirut Medical Center says the results establish strontium ranelate as an effective means to reduce fractures and treat osteoporosis. But more research is needed to better understand how it works and the drug's effect on bone.
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