In response to the concerns raised by Dr Rothschild1 in the June 12 issue of the ARCHIVES, it is correct that the Fracture Intervention Trial2 had as its primary end point the evaluation of fracture reduction; however, the assessment of safety and tolerability of alendronate sodium were also prespecified study objectives. The trial was designed to collect the necessary data to accomplish these aims and went beyond standard adverse experience collection for serious upper gastrointestinal (GI) tract events by having a blinded physician at the coordinating center evaluate the medical records of patients who experienced such events. Collection and review of supportive documentation were accomplished for 115 of the 124 patients in this category.
Bauer DC, for the Fracture Intervention Trial Research Group. Alendronate and Nonsteroidal Anti-inflammatory Drug Interaction Safety Is Not Established: A Reply. Arch Intern Med. 2000;160(17):2686-2687. doi: