Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE) is a randomised
      population-based study, including 20,904 Danish women aged 65-80 years, investigating the
      effectiveness of a two-step screening programme for osteoporosis, using a questionnaire based
      on FRAX® followed by DXA-scan of those at highest risk. Further, the study is expected to
      provide knowledge about cost-effectiveness, patient preferences and acceptance of screening
      programme to prevent fractures
    

Detailed description: 
      Osteoporosis is highly prevalent especially in postmenopausal women. Approximately 46 % of
      all women will suffer at least one osteoporotic fracture after the age of 50. The US
      Preventive Services Task Force (USPSTF) and National Osteoporosis Foundation (NOF) recommend
      screening with dual-energy x-ray absorptiometry (DXA) in all women aged 65 years and above
      regardless of risk factors. Nevertheless, the use of clinical risk factors has been shown to
      enhance the risk-gradient and accuracy of fracture risk prediction. The FRAX risk assessment
      score was derived from large population-based cohorts and validated in separate validation
      cohorts. Its use as a risk assessment tool is endorsed by WHO, but no prospective studies
      examining the effect of a screening programme using a combination of FRAX and DXA in a
      two-step manner have been performed previously.

      35,000 women aged 65-80 years were selected at random from the population in the Region of
      Southern Denmark and -before inclusion-randomised 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. The aim of the ROSE study is to investigate the
      effectiveness of a two-step population based osteoporosis screening programme using FRAX®
      based on self-administered questionnaire to select women for DXA followed by the standard
      osteoporosis treatment according to national guidelines and delivered by GPs in the Region of
      Southern Denmark. Secondary aims are to clarify whether the screening programme is
      cost-effective and to assess the patients' preferences, experience and acceptance of the
      screening programme. Moreover, sub-studies allow assessment of the effectiveness of FRAX®
      alone or combined with individual clinical risk factors in the prediction of fractures and
      the impact of socioeconomic factors for participation and outcome.
    

Intervention name(s): Screening; Control
Intervention type(s): Other; Other
Intervention description(s): Screening by risk factor assessment (FRAX) followed by DXA; Observation by use of register data
Other intervention name(s): DXA scan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Screening; Risk Assessment; Fractures; Absorptiometry, Photon; Fracture prevention; Women; Patient prespective