ORIGINAL ARTICLE Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study K. H. Rubin 1 & M. J. Rothmann 2,3 & T. Holmberg 4 & M. Høiberg 3,5 & S. Möller 1 & R. Barkmann 6 & C. C. Glüer 6 & A. P. Hermann 2,3 & M. Bech 7 & J. Gram 3,8 & K. Brixen 3 Received: 31 May 2017 /Accepted: 23 November 2017 # International Osteoporosis Foundation and National Osteoporosis Foundation 2017 Abstract Summary The Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study investigated the effectiveness of a two-step screening program for osteoporosis in women. We found no overall reduction in fractures from systematic screening compared to the current case-finding strategy. The group of moderate- to high-risk women, who accepted the invitation to DXA, seemed to benefit from the program. Introduction The purpose of the ROSE study was to investigate the effectiveness of a two-step population-based osteoporosis screening program using the Fracture Risk Assessment Tool (FRAX) derived from a self-administered questionnaire to select women for DXA scan. After the scanning, standard osteoporosis management according to Danish national guidelines was followed. Methods Participants were randomized to either screening or control group, and randomization was stratified according to age and area of residence. Inclusion took place from February 2010 to November 2011. Participants received a self-administered question- naire, and women in the screening group with a FRAX score ≥ 15% (major osteoporotic fractures) were invited to a DXA scan. Primary outcome was incident clinical fractures. Intention-to-treat analysis and two per-protocol analyses were performed. Results A total of 3416 fractures were observed during a median follow-up of 5 years. No significant differences were found in the intention-to-treat analyses with 34,229 women included aged 65–80 years. The per-protocol analyses showed a risk reduction in the group that underwent DXA scanning compared to women in the control group with a FRAX ≥ 15%, in regard to major osteoporotic fractures, hip fractures, and all fractures. The risk reduction was most pronounced for hip fractures (adjusted SHR 0.741, p = 0.007). Conclusions Compared to an office-based case-finding strategy, the two-step systematic screening strategy had no overall effect on fracture incidence. The two-step strategy seemed, however, to be beneficial in the group of women who were identified by FRAX as moderate- or high-risk patients and complied with DXA. Keywords Fracture . FRAX . Osteoporosis . Population-based screening . Prevention . Women * K. H. Rubin krubin@health.sdu.dk 1 OPEN—Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense C, Denmark 2 Department of Endocrinology, Odense University Hospital, Odense, Denmark 3 Department of Clinical Research, University of Southern Denmark, Odense, Denmark 4 National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark 5 Department of Research, Hospital of Southern Norway, Kristiansand, Norway 6 Department of Diagnostic Radiology, Molecular Imaging North Competence Center (MOIN CC), University Hospital Schleswig-Holstein in Kiel, Kiel, Germany 7 VIVE, The Danish Centre of Applied Social Science, Copenhagen, Denmark 8 Department of Endocrinology, Hospital of Southwest Denmark, Esbjerg, Denmark Osteoporosis International https://doi.org/10.1007/s00198-017-4326-3