Fifteen Minutes to Healthier Bones?
Annual injection of osteoporosis drug appears to help some people

(HealthDay News) -- For people who have trouble remembering to take medication daily (or weekly or monthly), a relatively new option is getting positive reviews: a once-a-year injection to combat osteoporosis.

Researchers have found that annual injections of zoledronic acid can help reduce the risk of fracture in older people and might also lower their risk of death, according to two studies in the New England Journal of Medicine .

"Here we've got something we can give to patients when they're in the clinic with a 15-minute IV, and it lasts for a whole year," Paul Brandt, an associate professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine, told HealthDay .

"We've been waiting for this for a long time. This is really exciting stuff," added Brandt, who was not involved in either study.

Dr. Kenneth Lyles, an author of one of the studies, concurred. "We changed the fracture rate and, when we analyzed the data, we had a significant mortality reduction. We never dreamed we'd have that," said Lyles, who is a professor of medicine and director of geriatrics research at Duke University Medical Center in Durham , N.C.

Both studies were funded by Novartis Pharmaceuticals, which makes Reclast, the injectable form of zoledronic acid.

Reclast is from a class of drugs known as bisphosphonates, medications that have been shown to increase bone mass and reduce the rate of fractures in the hip, spine and other areas, according to the National Institutes of Health. Some forms of bisphosphonates need to be taken daily, whereas others are weekly, twice a month, monthly or even quarterly. Reclast is the only once-a-year formulation. Side effects of the injected form include flu-like symptoms, fever, headache and muscle and joint pain.

The main problem with bisphosphonates has been what doctors call "patient compliance," Brandt said. That means people tend not to take the medication as they should. For instance, they forget to take the pills on the scheduled days or they don't follow the rules that say to take the medication while fasting and with a full glass of water.

"It's a pain to take these drugs," Brandt said. "You have to sit upright and there's a risk of acid reflux, esophageal damage."

Hence the interest in finding an alternative.

In one study, researchers followed 4,000 women randomly assigned to receive a 15-minute infusion of the drug or a placebo, and then subsequent infusions one and two years later. Treatment was linked to a 70 percent reduction in vertebral fractures.

The other study included 2,100 women and men who were randomized to receive either Reclast or a placebo after hip fracture surgery. New fractures were fewer among those given Reclast, and this group also recorded fewer deaths: about 10 percent, compared with 13 percent of those taking the placebo.

An annual injection "is a very attractive alternative for a significant number of people who cannot or will not take traditional antiresorptive medication," said Dr. Steven R. Goldstein, a professor of obstetrics and gynecology at New York University School of Medicine and author of The Estrogen Alternative .

"But this is not for everybody," he told HealthDay . "This study was in older people. So, in a select group of patients, this would be a very nice alternative. But it's not going to be a sea change, nor should younger people be running towards this methodology."

Dr. Nanette Santoro, director of reproductive endocrinology at Montefiore Medical Center in New York City , said that, for now, the most probable candidates for annual injections would be "women who do not tolerate oral bisphosphonates well." But looking further ahead, she said, "this may be a harbinger of how this class of medication will be given years from now."

On the Web

To learn more about osteoporosis, visit the Senior Health Web site of the National Institutes of Health.

SOURCES: HealthDay News ; Paul Brandt, Ph.D., associate professor of neuroscience and experimental therapeutics, College of Medicine, Texas A&M Health Science Center, College Station, Texas; Nanette Santoro, M.D., director, Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center, New York City; Steven R. Goldstein, M.D., professor of obstetrics and gynecology, New York University School of Medicine, New York City; Kenneth Lyles, M.D., professor of medicine and director of geriatrics research, Duke University Medical Center, Durham, N.C.; May 3, 2007, New England Journal of Medicine ; Sept. 19, 2007, New England Journal of Medicine ; National Institutes of Health (www.nih.gov)
Author: Serena Gordon
Publication Date: May 31, 2008
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