Felicia Cosman1, Jeri W Nieves2, Catherine Roimisher3, Simon Neubort3, Donald J McMahon3, David W Dempster4, Robert Lindsay5. 1. Regional Bone and Clinical Research Centers, Helen Hayes Hospital, West Haverstraw, NY 10993, United States of America; Department of Medicine, Columbia University, New York, NY 10032, United States of America. Electronic address: FC14@cumc.columbia.edu. 2. Regional Bone and Clinical Research Centers, Helen Hayes Hospital, West Haverstraw, NY 10993, United States of America; Department of Epidemiology, Columbia University, New York, NY 10032, United States of America. 3. Regional Bone and Clinical Research Centers, Helen Hayes Hospital, West Haverstraw, NY 10993, United States of America. 4. Regional Bone and Clinical Research Centers, Helen Hayes Hospital, West Haverstraw, NY 10993, United States of America; Department of Pathology and Cell Biology, Columbia University, New York, NY 10032, United States of America. 5. Regional Bone and Clinical Research Centers, Helen Hayes Hospital, West Haverstraw, NY 10993, United States of America; Department of Medicine, Columbia University, New York, NY 10032, United States of America.
Abstract
PURPOSE: We evaluated if equivalent doses of TPTD given cyclically over 4-years could increase BMD >2-years of daily TPTD in 2 cohorts of women; previously untreated (Rx-Naïve) and women previously treated with ALN (ALN-Rx). METHODS: In Rx-Naïve, women were randomized to daily TPTD for 24 months (Daily; n = 23) or cyclic TPTD for 48 months (3 months on, 3 months off; Cyclic; n = 25). In ALN-Rx, women were randomized to continued ALN plus daily TPTD for 24 months, followed by ALN alone for 24 months (Daily; n = 21) or TPTD for 48 months (3 months on, 3 months off) while ALN was continued (Cyclic; n = 20). BMD (DXA) was measured at spine (LS), total hip (TH) and femoral neck (FN). The primary analysis compared 4 years of cyclic therapy to 2 years of daily therapy in RX-naïve and ALN-RX cohorts. RESULTS: In Rx-Naïve, BMD changes at 24 months after Daily TPTD vs. 48 months after Cyclic TPTD were: LS 8.6% vs. 6.9%; TH 2.5% vs. 2.6%, and FN 1.6% vs. 2.2%. None of the BMD changes differed significantly between groups but all changes were significant over time within each group (p < 0.01 except for FN where p = 0.17 Daily; p = 0.09 Cyclic). In ALN-Rx, BMD changes at 24 months after Daily TPTD vs. 48 months after Cyclic TPTD were: LS 7.5% vs. 7.2%; TH 3.8% vs. 4.1%, and FN 3.2% vs. 2.5%. There were no differences between groups but all changes were significant within each group (p < 0.01). CONCLUSION: The same cumulative dose of TPTD given cyclically for 4-years, does not increase BMD more than standard daily TPTD over 2-years in either Rx-Naïve or ALN-Rx women. TRIAL REGISTRATION: NCT00668941.
RCT Entities:
PURPOSE: We evaluated if equivalent doses of TPTD given cyclically over 4-years could increase BMD >2-years of daily TPTD in 2 cohorts of women; previously untreated (Rx-Naïve) and women previously treated with ALN (ALN-Rx). METHODS: In Rx-Naïve, women were randomized to daily TPTD for 24 months (Daily; n = 23) or cyclic TPTD for 48 months (3 months on, 3 months off; Cyclic; n = 25). In ALN-Rx, women were randomized to continued ALN plus daily TPTD for 24 months, followed by ALN alone for 24 months (Daily; n = 21) or TPTD for 48 months (3 months on, 3 months off) while ALN was continued (Cyclic; n = 20). BMD (DXA) was measured at spine (LS), total hip (TH) and femoral neck (FN). The primary analysis compared 4 years of cyclic therapy to 2 years of daily therapy in RX-naïve and ALN-RX cohorts. RESULTS: In Rx-Naïve, BMD changes at 24 months after Daily TPTD vs. 48 months after Cyclic TPTD were: LS 8.6% vs. 6.9%; TH 2.5% vs. 2.6%, and FN 1.6% vs. 2.2%. None of the BMD changes differed significantly between groups but all changes were significant over time within each group (p < 0.01 except for FN where p = 0.17 Daily; p = 0.09 Cyclic). In ALN-Rx, BMD changes at 24 months after Daily TPTD vs. 48 months after Cyclic TPTD were: LS 7.5% vs. 7.2%; TH 3.8% vs. 4.1%, and FN 3.2% vs. 2.5%. There were no differences between groups but all changes were significant within each group (p < 0.01). CONCLUSION: The same cumulative dose of TPTD given cyclically for 4-years, does not increase BMD more than standard daily TPTD over 2-years in either Rx-Naïve or ALN-Rxwomen. TRIAL REGISTRATION: NCT00668941.
Authors: Francisco Torres-Naranjo; Pilar De la Peña-Rodríguez; Roberto Enrique López-Cervantes; Jorge Morales-Torres; Jorge Morales-Vargas; Hugo Gutiérrez-Hermosillo; Alan Christopher Guzmán-Rico; Roberto Gabriel González-Mendoza; Pedro Nel Rueda Plata; Miguel Flores Castro; Cuauhtémoc Celis Gonzalez; Rolando Espinosa Morales; Sergio Quintero Hernández; Juan Ricardo López-Taylor Journal: Arch Osteoporos Date: 2021-01-25 Impact factor: 2.617