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May 3, 2000

Raloxifene and Risk of Vertebral Fracture in Postmenopausal Women

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor

JAMA. 2000;283(17):2236-2237. doi:10.1001/jama.283.17.2235

To the Editor: Dr Ettinger and colleagues1 reported that raloxifene reduced the risk of vertebral fractures in postmenopausal women with osteoporosis. However, their study appears to have several methodological difficulties. First, it is not clear how well concealment of allocation was guaranteed. For instance, while 23% of the patients stopped taking the study medication, information on the reason for withdrawal was provided for only 10% who dropped out because of adverse effects. Furthermore, the data were not analyzed on an "intent-to-treat" basis; 11% of the subjects were excluded from the analysis for unstated reasons. Inclusion of their data may have changed the results.