OTTAWA, Canada—Alendronate can stave off vertebral, nonvertebral, hip, and wrist fractures among postmenopausal women with low bone density and/or those with previous fractures, according to an analysis in the Cochrane Database of Systematic Reviews.1

"At 10 mg per day, both clinically important and statistically significant reductions in vertebral, nonvertebral, hip, and wrist fractures were observed for secondary prevention, [but] we found no statistically significant results for primary prevention, with the exception of vertebral fractures, for which the reduction was clinically important," conclude researchers led by George A. Wells, PhD, of the department of epidemiology and community medicine at the University of Ottawa in Canada.
"At 10 mg per day, both clinically important and statistically significant reductions in vertebral, nonvertebral, hip, and wrist fractures were observed for secondary prevention, [but] we found no statistically significant results for primary prevention, with the exception of vertebral fractures, for which the reduction was clinically important."—George A. Wells, PhD.

Researchers analyzed 11 trials comprising 12,068 women. The study authors found that alendronate was effective in primary and secondary prevention against vertebral fractures. What's more, the drug showed statistically significant protection in secondary prevention against fractures of other bones, including those in the hip and wrist.

Specifically, there was a 45% relative risk reduction (RRR) for vertebral fractures among women taking the drug. This finding was significant for both primary prevention and secondary prevention, the study showed. There was a 16% RRR for nonvertebral fractures, which was significant for secondary prevention but not for primary prevention.

There was a 40% RRR for hip fractures among women taking alendronate as secondary prevention and a 50% RRR for wrist fractures in participants taking the drug for secondary prevention.

Alendronate was also found to be safe. "No increased incidence of adverse effects were detected with alendronate, but clinicians should be aware that outside of randomized controlled trials, concerns exist regarding the potential risk of upper gastrointestinal events and less commonly, osteonecrosis of the jaw," the study authors write.

To treat or not to treat? That is the question plaguing physicians

"Vertebral fracture risk reduction is solid across the board," said Ethel S. Siris, MD, the Madeline C. Stabile professor of clinical medicine and director of the Toni Stabile osteoporosis center at Columbia University Medical Center in New York City. "I don't want [physicians] to take away the idea that they should only use this drug in someone who already had a fracture." Other factors play a role in determining which patients to treat.

In the near future, a new algorithm by the World Health Organization (WHO) and guide by the National Osteoporosis Foundation (NOF) will help clinicians make more informed treatment decisions and hopefully prevent more fractures.

"If you just use T-scores as a way of determining risk for fracture, you get into a quandary," Dr. Siris continued. The newly developed algorithm incorporates several other risk factors to establish a person's 10-year risk of hip fracture.

WHO chose and evaluated risk factors that predict fracture risk independent of bone density, Dr. Siris explained. Such factors included age, history of previous fracture, parental fracture history, smoking, alcohol consumption, steroid use, and the presence of certain disease including rheumatoid arthritis that increase risk of osteoporosis.

When WHO releases the algorithm, the NOF will issue two papers including a physician guide with a section on treatment criteria that will incorporate the 10-year fracture probability. Software that helps doctors calculate this risk will quickly be distributed free of charge.

"This is going to be a big deal," Dr. Siris ended.

Reference

1. Wells GA, Cranney A, Peterson J, et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women (review) [published online ahead of print January 23, 2008]. Cochrane Database Syst Rev. 2008; doi:10.1002/14651858.CD001155.pub2. http://www.cochrane.org/reviews/en/ab001155.html.