Once-a-Year Bone Drug Lowers Fracture Risk

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.

Patients taking Reclast will also need to take vitamin D and calcium, they added, and some will experience flu-like symptoms which can be alleviated with a nonsteroidal anti-inflammatory drug.

"This appears to be the most potent of the bisphosphonates. It reduced bone turnover more and had a significant effect on fracture rate. The once-a-year dose obviously is attractive," said Dr. Stephen Honig, director of the Osteoporosis Center at the New York University Hospital for Joint Diseases. "This combination makes it potentially a very important drug. The caveat is the potential side effects. Other studies have found atrial fibrillation."

However, unlike one previous trial, the researchers on this study found no differences in reports of the irregular heartbeat known as atrial fibrillation between the two groups. They also found no reports of osteonecrosis of the jaw, a painful jaw condition, which had previously been associated with this class of drugs.

More information

There's more on osteoporosis at the National Osteoporosis Foundation.

SOURCES: Kenneth W. Lyles, M.D., professor of medicine and vice chairman for clinical research, department of medicine, Duke University Medical Center, Durham, N.C.; Paul Brandt, Ph.D., associate professor, neuroscience and experimental therapeutics, Texas A&M Health Science Center College of Medicine, College Station; Stephen Honig, M.D., director, Osteoporosis Center, New York University Hospital for Joint Diseases, New York City; Sept. 19, 2007,New England Journal of Medicine