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May 3, 2000

Raloxifene and Risk of Vertebral Fracture in Postmenopausal Women—Reply

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

In Reply: Patient allocation was performed using a randomization block design at each of the study sites. No individual involved with site contact or with data handling had access to treatment assignment prior to locking of the database. The quality assurance center responsible for judging the efficacy outcomes (from radiographs and bone density scans) had no access to treatment assignments.

In terms of the intent-to-treat analyses, the only other cause for discontinuation (besides an adverse event) that was different among treatment groups was early study completion due to excess bone loss or multiple fractures (4% of patients in the placebo group vs 1% in the raloxifene groups). While 23% of the women had discontinued the study medication by 36 months (25% of women in the placebo group and 22% of women assigned to raloxifene), follow-up radiographs were available for 89% of all women randomized. The 11% of patients who did not have a follow-up radiograph were equally distributed among treatment groups and had similar baseline characteristics such as number of prevalent fractures, bone mineral density, and bone marker levels; thus, it is very unlikely that those in the treatment and placebo groups had substantially different rates of fracture that could have altered the outcome. It is also extremely unlikely that all 11% experienced fractures, as Dr Halbekath and colleagues suggest.

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