Procedures
ADVERSE EVENTS
We recruited participants via the dual-energy x-ray absorptiometry (DXA) service at the Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark. All participants were referred from their general practitioner or other hospital department for evaluation by DXA. We identified women with osteopenia or osteoporosis (BMD T-score <− 1 at lumbar spine or total hip) and reviewed their medical records for any exclusion criteria. Women who were still eligible at this stage were sent a letter with written information about the project and contacted the investigator by telephone if they were interested in further information and participation in a screening visit.Written informed consent was obtained from all participants included in this study before the first procedures were performed.At the screening visit, we acquired information on medical history, prescription medication, calcium intake, age at menopause, smoking history and performed a medical examination. Furthermore, a screening blood test was analyzed to rule out presence of the exclusion criteria mentioned above. Bone turnover marker CTx was measured and women with CTx > 420 ng/L were included if they did not meet any exclusion criteria.We collected fasting blood samples at baseline and at weeks 4, 8, and 16. Information on adverse events (AEs) was obtained at each visit. Participants were provided with tablets for the entire study period at baseline and were instructed regarding the administration of the medication. The ALN group should swallow the pill with a glass of water and the ALN-EFF group had to dissolve the effervescent tablet in water and drink it immediately. Both groups were instructed to take the medication fasting in the morning and allow 30 min before consuming food/drinks and that they should not lay down but remain upright. At week 8 and week 16 participants were instructed to bring the remaining tablets and compliance was assessed by tablet count (Fig. Study design