The Risk-Stratified Osteoporosis Strategy Evaluation study (ROSE): A Randomized Prospective Population-Based Study. Design and Baseline Characteristics
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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.
KeywordsRisk factors Fracture prevention Osteoporosis Screening Women
Participants in the Rose study and technical staff in the four involved hospitals: Odense University Hospital, Odense; Hospital of Funen, Nyborg; Hospital of Southwest Denmark, Esbjerg, and Sygehus Lillebælt Hospital, Kolding, Denmark.
Conflict of interest
Katrine Hass Rubin, Teresa Holmberg, Mikkel Høiberg, Reinhard Barkmann, Jeppe Gram, Mickael Bech, Ole Rasmussen, Claus C Glüer have no conflict of interest. Mette Juel Rothmann: Amgen (Financial support for attending congress) and Eli Lilly (Consultation and advisory board). Anne Pernille Hermann: Eli Lilly, MSD, and Amgen (Advisory Board) and Amgen, Lilly, Genzyme (Speakers Bureau). Kim Brixen: Consulting (study design) MSD, Investigator MSD, Amgen, Novartis, NPS, Speakers bureau Amgen, GlaxoSmithKline, Grants MSD.
Human and Animal Rights and Informed Consent
The ROSE study is performed according to the declaration of Helsinki II and is approved by the Regional Scientific Ethical Committee for Southern Denmark (jr.nr S-20090127) and the Danish Data Protection Agency. The study is furthermore registered in ClinicalTrials.gov (NCT01388244). Women invited for DXA receive oral and written information before signing informed consent.
- 6.Wells GA, Cranney A, Peterson J, Boucher M, Shea B, Robinson V, Coyle D, Tugwell P (2008) Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 23:CD001155Google Scholar
- 7.Ettinger B, Black DM, Mitlak BH et al (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282:637–645CrossRefPubMedGoogle Scholar
- 14.Dansk Knoglemedicinsk S, Danish Bonemedical S (2009) Vejledning til udredning og behandling of Osteoporose. [Instrutions to diagnosis and treatment of osteoporosis]Google Scholar
- 18.National Osteoporosis F (2013) Clinicianïs guide to prevention and treatment of osteoporosis. National Osteoporosis Foundation, Washington DCGoogle Scholar
- 26.Dachverband Osteologie (2011) DVO Guideline 2009 for prevention, diagnosis and Therapy of osteoporosis in adults. Osteologie 20:55–74Google Scholar
- 30.DHaMA (Sundhedsstyrelsen) (2013) Guiding criteria for single reimbursement. http://sundhedsstyrelsen.dk/en/medicines/reimbursement/individual-reimbursement/single-reimbursement/guiding-criteria
- 46.World Health O (2011) WHO Fractures risk assessment tool. http://www.shef.ac.uk/FRAX/tool.aspx?country=29