Cosman F.,Regional Bone Center and Clinical Research Centers |
Cosman F.,Columbia University |
Nieves J.W.,Regional Bone Center and Clinical Research Centers |
Nieves J.W.,Columbia University |
And 7 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2015
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-fold greater in daily vs cyclic groups (LS, 8.8 vs 4.8%; TH, 4.0 vs 2.1%; Troch, 5.6 vs 3.1%; and FN, 2.9 vs 1.2%; group differences, all P<05). In daily vs cyclic groups, radiusBMD declined (-4.2 vs 2.1%, respectively; both P=.01; group difference, P=.08) and total bone mineral increased modestly (1.4%, P=.18; vs 1.5%, P=.06; group difference, not significant). In ALN-Rx women, there were no group differences (daily vs cyclic: LS, 7.5 and 6.0%; TH, 3 and 2.5%; Troch, 3.7 and 3.3%; FN, 3 and 1.5%; within groups, P=.003; except cyclic FN, P=.2). In daily and cyclic groups, radius BMD decreased (-0.7% [not significant] and 1.4% [P=.05], respectively), and total bone mineral increased 2.3 and 3% (both P=.001). Conclusion: Cyclic TPTD over 2 years improves BMD similarly to daily treatment in women who remain on ALN, despite only 50% of the TPTD dose. However, there does not appear to be a BMD advantage to cyclic administration in treatment-naive women for up to 24 months. Copyright © 2015 by the Endocrine Society.