Retreatment with teriparatide one year after the first teriparatide course in patients on continued long-term...

Patients treated with teriparatide after prior and ongoing alendronate therapy experience spine BMD increases; however, some continue to be at high risk for fracture, based on persistently low BMD and/or fracture history. The objective of this study was to determine whether a second discrete retreatment course with teriparatide could produce similar biochemical and BMD changes as seen during the first teriparatide course. In the original treatment study, 126 women on alendronate for >or=1 yr were randomized to continue alendronate and receive daily teriparatide, cyclic teriparatide (3-mo cycles), or alendronate alone for 15 mo. Of the 72 patients who completed either original teriparatide regimen, 49 completed a 12-mo follow-up on continued alendronate alone. At that time, 32 patients, who remained at high risk of future fracture, were recruited into the retreatment protocol and 27 completed another course of teriparatide administered daily for 15 mo (including 15 from the original daily treatment group and 12 from the original cyclic treatment group). Bone formation indices (propeptide of type I procollagen and osteocalcin) increased during both teriparatide courses with median 3-mo increments of 120% and 72% above baseline during the original course and 60% and 40% above baseline during retreatment, respectively. Mean spine BMD increments were 6.2% after the first daily course and 4.7% after retreatment and 4.1% after the first course of cyclic teriparatide and 4.9% after retreatment. We conclude that retreatment with teriparatide stimulates bone formation and increases spine BMD to a similar extent as seen during the original teriparatide course. Retreatment with teriparatide may be a viable option for some patients with severe osteoporosis who have received prior teriparatide therapy.