Daily or Cyclical Teriparatide Treatment in Women With Osteoporosis on no Prior Therapy and Women on Alendronate.

Context: Intermittent 3-month cyclic administration might optimize the anabolic potential of teriparatide (TPTD). Objective: To determine whether 3-month cyclical TPTD would produce a similar bone mineral density (BMD) response to daily therapy in treatment naive (Rx-naive) women and to confirm the results in alendronate (ALN)-treated (ALN-Rx) women over 24 months. Design: Subjects participated in a randomized open-label study for 2 years. Setting: Osteoporosis clinical research center. Participants: A total of 150 postmenopausal women with osteoporosis in two cohorts: 86 Rx-naive and 64 ALN-Rx. Intervention: Within cohorts, women were randomized to daily TPTD for 24 months or four 3-month TPTD cycles, each followed by 3 months off (12 mo total TPTD). Main Outcomes: BMD at 24 months. Results: In Rx-naive women, BMD increased in the lumbar spine (LS), total hip (TH), trochanter (Troch), and femoral neck (FN) in daily and cyclic groups (within groups, P < .0002, except cyclic FN, P = .13). Increases were 2-...