Study Design
We conducted a 16-week prospective, randomized, open-label study comprising 64 postmenopausal women with a BMD T-score <− 1. Participants were randomized 1:1 to two groups of 32 women each. One group received branded ALN and the other ALN-EFF 70 mg weekly. In addition, all women received daily supplementation of 800 mg calcium and 38 µg vitamin D.We conducted the trial according to the Helsinki Declaration, the Danish Health Law, and GCP guidelines. The Danish Data Protection Agency (1-16-02-306-21), The Regional Ethics Committee (Eudract No. 2020-005040-35) and The Danish Health and Medicine Authority (2020-120512) approved the study. The local Good Clinical Practice (GCP) at Aalborg and Aarhus University Hospital monitored the trial. The trial is registered at clinicaltrials.gov (identifier NCT05325515).