• Felicia Cosman, Jeri W Nieves, Marsha Zion, Patricia Garrett, Simon Neubort, David Dempster, and Robert Lindsay.
• Regional Bone Center and Clinical Research Centers (F.C., J.W.N., M.Z., P.G., S.N., D.D., R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993; and Departments of Medicine (F.C., R.L.), Epidemiology (J.W.N.), and Pathology and Cell Biology (D.D.), Columbia University, New York, New York 10032.
• J. Clin. Endocrinol. Metab. 2015 Jul 1;100(7):2769-76.

ContextIntermittent 3-month cyclic administration might optimize the anabolic potential of teriparatide (TPTD).ObjectiveTo 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.DesignSubjects participated in a randomized open-label study for 2 years.SettingOsteoporosis clinical research center.ParticipantsA total of 150 postmenopausal women with osteoporosis in two cohorts: 86 Rx-naive and 64 ALN-Rx.InterventionWithin 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 OutcomesBMD at 24 months.ResultsIn 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, radius BMD 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).ConclusionCyclic 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.

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