@dvargo
According to the press release, a transiliac crest bone biopsy substudy in a subset of the ~750 participants in the Phase 3 trial is planned for histomorphometry. This is consistent with the pivotal studies of all other anabolic osteoporosis drugs, which also included bone biopsy substudies. Since the active drug - PTH(1-34) or teriparatide - is the same as in Forteo, the biopsy in Phase 3 will confirm whether oral administration also results in normal-quality bone, similar to what has been observed with the injectable form.