title: The risk-stratified osteoporosis strategy evaluation study (ROSE): a randomized prospective population-based study. Design and baseline characteristics.
abstract: The risk-stratified osteoporosis strategy evaluation study (ROSE) is a randomized prospective population-based study investigating the effectiveness of a two-step screening program for osteoporosis in women. This paper reports the study design and baseline characteristics of the study population. 35,000 women aged 65-80 years were selected at random from the population in the Region of Southern Denmark and-before inclusion-randomized to either a screening group or a control group. As first step, a self-administered questionnaire regarding risk factors for osteoporosis based on FRAX(®) was issued to both groups. As second step, subjects in the screening group with a 10-year probability of major osteoporotic fractures ≥15% were offered a DXA scan. Patients diagnosed with osteoporosis from the DXA scan were advised to see their GP and discuss pharmaceutical treatment according to Danish National guidelines. The primary outcome is incident clinical fractures as evaluated through annual follow-up using the Danish National Patient Registry. The secondary outcomes are cost-effectiveness, participation rate, and patient preferences. 20,904 (60%) women participated and included in the baseline analyses (10,411 in screening and 10,949 in control group). The mean age was 71 years. As expected by randomization, the screening and control groups had similar baseline characteristics. Screening for osteoporosis is at present not evidence based according to the WHO screening criteria. The ROSE study is expected to provide knowledge of the effectiveness of a screening strategy that may be implemented in health care systems to prevent fractures.
authors.affiliation: Odense Patient data Explorative Network (OPEN), Institute of Clinical Research, University of Southern Denmark, J. B. Winsløws Vej 9 a, 3th Floor, 5000, Odense C, Denmark, krubin@health.sdu.dk.
authors.forename: Katrine Hass
authors.initials: KH
authors.lastname: Rubin
authors.forename: Teresa
authors.initials: T
authors.lastname: Holmberg
authors.forename: Mette Juel
authors.initials: MJ
authors.lastname: Rothmann
authors.forename: Mikkel
authors.initials: M
authors.lastname: Høiberg
authors.forename: Reinhard
authors.initials: R
authors.lastname: Barkmann
authors.forename: Jeppe
authors.initials: J
authors.lastname: Gram
authors.forename: Anne Pernille
authors.initials: AP
authors.lastname: Hermann
authors.forename: Mickael
authors.initials: M
authors.lastname: Bech
authors.forename: Ole
authors.initials: O
authors.lastname: Rasmussen
authors.forename: Claus C
authors.initials: CC
authors.lastname: Glüer
authors.forename: Kim
authors.initials: K
authors.lastname: Brixen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000502:physiology*; D003362:Cost-Benefit Analysis; D003718:Denmark; D005260:Female; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy* / Q000191:economics; D058866:Osteoporotic Fractures / Q000175:diagnosis* / Q000191:economics* / Q000628:therapy; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires