Felicia Cosman1, Jeri W Nieves1, Marsha Zion1, Patricia Garrett1, Simon Neubort1, David Dempster1, Robert Lindsay1. 1. 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.
Abstract
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, 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). 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.
RCT Entities:
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, 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-Rxwomen, 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.
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