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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.

Second, the authors report that 87% of the vertebral fractures were silent and discovered only on radiological examination. However, the clinical relevance of preventing silent vertebral fractures was not evaluated and remains unproven. Although they refer to an epidemiological study that assessed the clinical consequences of vertebral . . . [Full Text of this Article]

RELATED ARTICLE

Reduction of Vertebral Fracture Risk in Postmenopausal Women With Osteoporosis Treated With Raloxifene: Results From a 3-Year Randomized Clinical Trial
Bruce Ettinger, Dennis M. Black, Bruce H. Mitlak, Ronald K. Knickerbocker, Thomas Nickelsen, Harry K. Genant, Claus Christiansen, Pierre D. Delmas, Jose R. Zanchetta, Jacob Stakkestad, Claus C. Glüer, Kathryn Krueger, Fredric J. Cohen, Stephen Eckert, Kristine E. Ensrud, Louis V. Avioli, Paul Lips, Steven R. Cummings, and for the Multiple Outcomes of Raloxifene Evaluation Investigators
JAMA. 1999;282(7):637-645.
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