Study subjects and ordinary patients

Clinical trials of treatment agents impose strict and often necessary inclu sion and exclusion criteria, while patients presenting to physicians for tr eatment frequently exhibit complicating features that would have excluded t hem from entry into study. To quantify the degree of discordance between or dinary patients and study subjects, a retrospective chart review was carrie d out of all new patients with osteoporosis seen in an academic medical cen ter within a consecutive 40-month period, meeting clinical treatment criter ia. Each patient chart was reviewed for the inclusion and exclusion criteri a of four large, multicenter study protocols. There were 120 consecutive fe male patients seeking health care, with bone density T-scores below -2.0 an d/or with one or more low-trauma fractures. The four trials would have acce pted 4, 5, 25 and 8 of our 120 patients. The trial with the most liberal in clusion criteria would have taken only 21% of the total. Principal reasons for ineligibility were comorbidity, prior treatment with bone-active agents , and current therapy with glucocorticoids, anticoagulants and anticonvulsa nts. Some of these exclusions inevitably reflect the patient mix of a refer ral center; nevertheless, comorbidity and its therapy are common in the age range in which osteoporosis is prevalent and would, therefore, be expected to be present in patients in general medical practice as well. Thus a larg e fraction, perhaps the majority, of patients with diagnoses of osteoporosi s who are candidates for treatment by their physicians, are not eligible fo r entry into typical treatment trials. The results of such trials may, ther efore, have uncertain applicability to types of patients excluded, both for safety and for efficacy.