Scientists discuss the ethics of placebo-controlled studies for osteoporosis research

In an essay appearing in this week's issue of the New England Journal of Medicine, two researchers, Clifford Rosen and Sundeep Khosla, wrote that placebo-controlled trials of new osteoporosis drugs can be performed ethically, if patient selection and other design issues are handled carefully.

MedPage Today reports that two Vanderbilt University researchers wrote in a companion essay that patients assigned to placebo would nearly always suffer more fractures than they would if they were taking an approved osteoporosis drug. As a result, placebo-controlled studies "will nearly always be unethical," according to C. Michael Stein and Wayne A. Ray.

Rosen and Khosla pointed to several past placebo-controlled trials of osteoporosis therapies that they argued produced benefits that outweighed the risk burden put on the placebo groups. They cited a recent placebo-controlled study of denosumab that identified potential side effects that were previously unrecognized.

In addition, they noted that major drug regulators including the FDA sanction the use of placebo controls in osteoporosis drug trials, and that the Helsinki Declaration on research ethics allows for placebo controls as long as "no major harm" is expected.

According to the National Osteoporosis Foundation, approximately eight million women and two million men have osteoporosis in the U.S.
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