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Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study

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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 questionnaire, 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.

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Acknowledgements

We thank the participants in the ROSE study and the technical staff in the four involved hospitals: Odense University Hospital, Odense and Nyborg; Hospital of Southwest Denmark, Esbjerg; and Sygehus Lillebælt Hospital, Kolding, Denmark. Claire Gudex is thanked for linguistic editing and proofreading of the manuscript.

Funding

The ROSE study was supported by INTERREG (4A JNR 08/4177), the Region of Southern Denmark (JNR 08/8133), and Odense University Hospital (JNR 11/5761). The funding agencies had no direct role in the conduct of the study, data collection, analysis, and interpretation of the data or the preparation, review, and final approval of the manuscript.

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Authors and Affiliations

  1. OPEN—Odense Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark and Odense University Hospital, Odense C, Denmark

    K. H. Rubin & S. Möller

  2. Department of Endocrinology, Odense University Hospital, Odense, Denmark

    M. J. Rothmann & A. P. Hermann

  3. Department of Clinical Research, University of Southern Denmark, Odense, Denmark

    M. J. Rothmann, M. Høiberg, A. P. Hermann, J. Gram & K. Brixen

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

    T. Holmberg

  5. Department of Research, Hospital of Southern Norway, Kristiansand, Norway

    M. Høiberg

  6. Department of Diagnostic Radiology, Molecular Imaging North Competence Center (MOIN CC), University Hospital Schleswig-Holstein in Kiel, Kiel, Germany

    R. Barkmann & C. C. Glüer

  7. VIVE, The Danish Centre of Applied Social Science, Copenhagen, Denmark

    M. Bech

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

    J. Gram

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  1. K. H. Rubin
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Correspondence to K. H. Rubin.

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Conflicts of interest

SM, TH, MB, JG, RB, CCG, and KHR have no conflict of interest. MJR has received speaker fee from Eli Lilly. MH is a full-time employee of Boehringer-Ingelheim Norway KS (currently). APH serves on advisory boards for Eli Lilly and Amgen, and she has received research funding from Eli Lilly, speaker fee from Eli Lilly, GSK, Genzyme, and Amgen; KB reports other from Merck, Sharpe, and Dohme, other from Amgen, other from Novartis, and other from NPS, all outside the submitted work.

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Rubin, K.H., Rothmann, M.J., Holmberg, T. et al. Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study. Osteoporos Int 29, 567–578 (2018). https://doi.org/10.1007/s00198-017-4326-3

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