Once-a-Year Bone Drug Lowers Fracture Risk

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Many such fractures are the result of osteoporosis, a disease which primarily affects women in their postmenopausal years. With this disease, bones thin out and become more fragile, causing them to break more easily. Fracture can often result in severe disability, even death.

Reclast was approved in August by the U.S. Food and Drug Administration to treat osteoporosis in postmenopausal women.

The drug is a bisphosphonate, a class of drugs which also includes Fosamax, Actonel and Boniva. These medications -- the most commonly used treatments for osteoporosis -- work by slowing the body's natural reabsorption of bone.

While the drugs are effective, there has been a problem with getting patients to take them as they should.

For this study, more than 2,100 men and women were randomized to receive Reclast or a placebo within 90 days after surgery for a hip fracture. Participants were followed for an average of almost two years.

Almost 14 percent of those not taking Reclast suffered a new fracture, the researchers found, compared with only 8.6 percent of those taking the drug. Also, 13.3 percent of patients not taking Reclast died, versus 9.6 percent of those taking the drug.

In the end, patients taking Reclast were 28 percent less likely to die and 35 percent less likely to have another fracture than those on placebo.

Bone mineral density also increased in the Reclast group, the team reported.

It seems likely that the decline in mortality was due at least in part to the decline in fractures, the authors stated.

Only 43 percent of participants were classified as having osteoporosis but most likely had some weakening of the bone. "What's happening here is that you have a thinning of the bone that isn't being detected by a scan," Brandt said.

There were some concerns about the design of the trial. For example, patients in the placebo arm did not receive another medication, although many did receive bone-boosting vitamin D. However, the authors noted that the patients enrolled in this trial could not or would not take an oral bisphosphonate.