BioCentury
ARTICLE | Clinical News

Bisphosphonate uncertainties linger at FDA

May 11, 2012 1:22 AM UTC

Eight months after an FDA panel recommended clarifying the duration of use in labels of bisphosphonates for osteoporosis, the agency said further investigation on the benefit-risk profile is still needed to determine the best long-term treatment regimen. In a perspective paper published in the New England Journal of Medicine, FDA said pooled data of patients receiving continuous bisphosphonate treatment for six years or more led to fracture rates of 9.3-10.6% compared to 8-8.8% for patients switching to placebo at five years. The agency said these data raise the question of whether continued treatment with bisphosphonates provides an additional fracture-prevention benefit. FDA also noted that statistical limitations preclude inferring any meaningful association between long-term treatment and increased risk of fracture.

In a separate perspective, researchers at the University of California, San Francisco and colleagues said recommendations for discontinuation of bisphosphonates need to be drug-specific. They also agreed that further study is needed to determine recommendations about monitoring after discontinuation and reinitiating antifracture therapy (see BioCentury Extra, Sept. 9, 2011). ...