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The Risk-Stratified Osteoporosis Strategy Evaluation study (ROSE): A Randomized Prospective Population-Based Study. Design and Baseline Characteristics

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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.

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Acknowledgments

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.

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Authors and Affiliations

  1. 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

    Katrine Hass Rubin

  2. National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark

    Teresa Holmberg

  3. Department of Medical Endocrinology, Odense University Hospital, Odense C, Denmark

    Mette Juel Rothmann, Anne Pernille Hermann & Kim Brixen

  4. Department of Medical Endocrinology, Oslo University Hospital Aker, Oslo, Norway

    Mikkel Høiberg

  5. Section Biomedical Imaging, Department of Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Kiel, Germany

    Reinhard Barkmann & Claus C. Glüer

  6. Department of Endocrinology, Hospital of Southwest Denmark, Esbjerg, Denmark

    Jeppe Gram

  7. Department of Business and Economics, COHERE, University of Southern Denmark, Odense, Denmark

    Mickael Bech

  8. Department of Internal Medicine, Sygehus Lillebælt, Kolding, Denmark

    Ole Rasmussen

  9. Institute of Clinical Research, University of Southern Denmark, Odense, Denmark

    Mette Juel Rothmann & Kim Brixen

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  1. Katrine Hass Rubin
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Correspondence to Katrine Hass Rubin.

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Rubin, K.H., Holmberg, T., Rothmann, M.J. et al. The Risk-Stratified Osteoporosis Strategy Evaluation study (ROSE): A Randomized Prospective Population-Based Study. Design and Baseline Characteristics. Calcif Tissue Int 96, 167–179 (2015). https://doi.org/10.1007/s00223-014-9950-8

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