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No Increased Osteoporosis Risk with Break from Alendronate
Written by Jeanne Bohm, Ph.D.   
Most postmenopausal women who took the osteoporosis drug alendronate for 5 years and then stopped did not have an increased risk for nonvertebral fractures in the next 5 years, according to a study in the December 27 issue of JAMA.

Osteoporosis is characterized by increased bone turnover, progressive loss of bone mass and increased fracture risk. Bisphosphonates are the most commonly used medications for postmenopausal osteoporosis. Alendronate, a bisphosphonate, decreases bone turnover, increases bone mineral density (BMD), and decreases fracture risk in women.

Treatment for osteoporosis normally continues for the rest of the patient's lifetime, but few studies have examined the effects of using  bisphosphonates longer than 5 years or stopping treatment after 5 years. Some studies have suggested that stopping treatment after several years might result in continued effectiveness because of a residual effect of the drug but the results are uncertain.

The Fracture Intervention Trial (FIT), a randomized, blinded, placebo-controlled trial, examined the effect of daily alendronate on BMD and fracture risk in postmenopausal women with low BMD with an average follow-up of 3.8 years. Dennis M. Black, Ph.D., of the University of California, San Francisco, and colleagues analyzed data from the FIT Long-term Extension (FLEX), designed to evaluate the effects on BMD of either alendronate (10 years treatment) or discontinuation after approximately 5 years. The trial was conducted at 10 clinical centers with 1,099 postmenopausal women.

The researchers found that compared with continuing alendronate, switching to placebo for 5 years resulted in average levels remaining at or above pretreatment levels. Similarly, those discontinuing alendronate had bone marker levels remaining below pretreatment levels. After 5 years, the cumulative risk of nonvertebral fractures was not significantly different between those continuing (19 percent) and discontinuing (18.9 percent) alendronate. Among patients continuing alendronate, there was a 55 percent lower risk of clinically recognized vertebral fractures.

The data suggest there is some residual effect from 5 years of alendronate treatment evident for at least 5 years after discontinuation. The results suggest taking of alendronate for 10 years maintains a higher bone mass and reduces bone remodeling compared with discontinuation after 5 years. However, even when therapy was discontinued after 5 years, BMD remained at or above baseline values and bone turnover was still reduced. Discontinuation after 5 years also did not increase the risk of nonvertebral fractures or x-ray–detected vertebral fractures but women did have an increased risk of clinically diagnosed vertebral fractures.

The authors concluded that the results suggest discontinuation of alendronate after 5 years does not significantly increase nonvertebral fracture risk, but does increase the risk of clinical vertebral fractures.


JAMA Media Release

Effects of Continuing or Stopping Alendronate After 5 Years of Treatment: The Fracture Intervention Trial Long-term Extension (FLEX): A Randomized Trial. JAMA. 2006;296:2927-2938.

About the Author

Jeanne Bohm, Ph.D. is a cancer biologist by training, a medical writer and an experienced science educator.

The author has no financial relationship to any of the companies listed in the article.


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