Diagnostic Thresholds in Osteoporosis: How Are They Used in Clinical Trials?

Abstract

Clinical trials are used to determine the efficacy and safety of a medication prior to approval for commercial use and to influence the prescribing habits of clinicians. The lack of uniformity in the diagnostic thresholds used in clinical trials on osteoporosis makes it difficult to compare the results of these trials. The use of placebo, different anatomical sites, T-score cutoff points, and risk factors precludes any meaningful comparison being made between the outcomes of clinical trials. Finally, the lack of uniform reporting format makes it difficult to retrieve important information to compare one medication to another. Because the diagnostic thresholds used affect the outcomes of these trials, health care providers need to be aware of these criteria to determine whether the results of a particular clinical trial can be applied to a particular patient.