Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) study.

The experience in randomized placebo-controlled clinical trials may differ from that in community practice. The pivotal teriparatide [rhPTH(1-34)] studies were initiated when few therapeutic options for osteoporosis were available. The Direct Analysis of Non-Vertebral Fractures in Community Experience (DANCE) study is a prospective observational trial designed to examine the occurrence of nonvertebral fragility fractures in a large, diverse patient population treated with teriparatide. The occurrence of clinical vertebral fractures and back pain will also be examined, as will bone mineral density, bone mineral content, bone area, safety and tolerability. Subjects will be followed through a course of teriparatide therapy for up to 24 months and for an additional 24 months after cessation of treatment. Therefore, subjects may participate in this study for up to 48 months. DANCE will provide data on the effectiveness and tolerability of teriparatide therapy in clinical practice that will complement the results of published controlled clinical trials.