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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