Placebo-Controlled Fracture Trials in Osteoporosis — Comment on the Article by Rosen and Khosla
- 30 September 2010
- journal article
- letter
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 363 (14) , e22
- https://doi.org/10.1056/nejmpv1008670
Abstract
Rosen and Khosla review the arguments that are often advanced to provide support for placebo-controlled fracture trials in osteoporosis, which we discuss in our article. The undeniable crux of these arguments is that such trials are the most direct and cost-effective way to obtain high-quality scientific evidence of the efficacy and safety of new therapies. Nevertheless, because patients are involved, it is unethical to withhold a treatment that has been proved to prevent major harm such as fractures. Rosen and Khosla acknowledge this fact, noting that “trial design and implementation should not supersede patient welfare.” Thus, ethical considerations must be foremost in trial design; convenience cannot trump patient well-being.Keywords
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