A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.
Inclusion Criteria:
Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:
BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
Exclusion Criteria:
Ciudad Autonoma de Buenos Aires, Buenos Aires 1114, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1430CKE, Argentina
Westmout, Quebec H3Z 1E5, Canada
Bogota, Cundinamarca 11001000, Colombia
Bogota, Cundinamarca 110221, Colombia
Bogota, Cundinamarca, Colombia
Ostrava-Trebovice, 722 00, Czechia
Århus C, 8000, Denmark
Lyon Cédex 3, 69437, France
Arenzano GE, 16011, Italy
Mexicalli, Baja California Norte 21200, Mexico
Grafton, Auckland, 1023, New Zealand
Dabrowka Dopiewo, 62-069, Poland
Kosice-Saca, 040 15, Slovakia
Tygerberg, 7505, South Africa
Suwon-si, Gyeonggi-do, 443-380, South Korea
Staffordshire, WS11 5XY, United Kingdom