January 24, 2008
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Systematic review shows alendronate significantly reduces postmenopausal osteoporotic fracture risk

Daily treatment with alendronate conferred a significant relative risk reduction for nonvertebral fractures, but only for secondary prevention.

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Treating postmenopausal women who have osteoporosis with daily 10-mg doses of alendronate can significantly reduce their risk of primary and secondary osteoporotic fractures, according to a meta-analysis published in the Cochrane Database of Systematic Reviews.

George A. Wells, MSc, PhD, a professor in the department of epidemiology and community medicine at the University of Ottawa, Canada, and colleagues conducted the study.

The researchers searched the CENTRAL, MEDLINE and EMBASE databases to identify relevant randomized, controlled trials evaluating the efficacy of alendronate published between 1966 and 2007. They focused on trials involving women who received at least 1 year of treatment with alendronate for postmenopausal osteoporosis in comparison to women who received either placebo or calcium/vitamin D, or both.

The review included 11 trials involving 12,068 women, according to the study.

"We undertook study selection and data abstraction in duplicate. We performed meta-analysis of fracture outcomes using relative risks, and a [greater than] 15% relative change was considered clinically important. We assessed study quality through reporting of allocation concealment, blinding and withdrawals," the authors wrote in the study.

The researchers found that treatment with a daily 10-mg dose of alendronate was associated with a significant reduction in vertebral fracture risk. Specifically, there was a 45% relative risk reduction and 2% absolute risk reduction for primary prevention, and a 45% relative risk reduction and 6% absolute risk reduction for secondary prevention, according to the study.

They also found a significant 16% relative risk reduction for nonvertebral fractures. However, it was only significant for secondary prevention, with a 23% relative risk reduction and a 2% absolute risk reduction.

Regarding other nonvertebral fractures, daily alendronate treatment only showed a significant effect on secondary fracture prevention. Specifically, the researchers found a 40% relative risk reduction in hip fractures, with a 53% relative risk reduction and 1% absolute risk reduction for secondary prevention.

For wrist fractures, alendronate produced a 50% relative risk reduction and 2% absolute risk reduction for secondary prevention, according to the study.

"At 10 mg per day, both clinically important and statistically significant reductions in vertebral, nonvertebral, hip and wrist fractures were observed for secondary prevention. We found no statistically significant results for primary prevention, with the exception of vertebral fractures, for which the reduction was clinically important," the authors wrote.

"For adverse events, we found no statistically significant differences in any included study. However, observational data raise concerns regarding the potential risk for upper gastrointestinal injury and, less commonly, osteonecrosis of the jaw," they noted.

For more information:

  • Wells GA, Cranney A, Peterson J, et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008;1. Art. No.: CD001155. DOI: 10.1002/14651858.CD001155.pub2.