Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

• The effect of screening for osteoporosis with a two-step programme involving FRAX risk score followed by DXA for the prevention of hip fracture and other osteoporosis-related fracture events [ Time Frame: Three years follow-up on average ] [ Designated as safety issue: No ]
  Comparison of register data concerning hospitalizations for primarily hip fracture between the intervention and control group as a whole. Power calculations suggest three years of followup on average, but this time frame could be increased if participation falls short.
  
  

• Cost-effectiveness / cost-utility of a two-step screening programme. [ Time Frame: Three years follow-up on average ] [ Designated as safety issue: No ]
  Comparison of register-based health related costs due to antiosteoporotic medications combined with generated costs due to hospitalizations for osteoporosis-related fractures. Follow-up time is defined by the primary outcome measure
  
  

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.

Therefore, 50.000 women aged 65-80 years are randomized in a 1:1 fashion to a screening arm and a control arm. Participants receive a letter of invitation together with a questionnaire based survey with 25 questions including FRAX risk score elements. In the screening arm, all participants with a calculated 10-year risk of major osteoporotic fracture above 15 percent are invited to a DXA examination. The primary physicians of scanned participants receive information about scanning results, and medical secondary prevention is recommended for participants diagnosed with osteoporosis (T-score < -2,5, WHO definition) and initiated by the primary physician.

The aim of the study is to investigate the effect of a risk-stratified screening programme in preventing fractures in the general population of women aged 65-80. Secondary end points examine the acceptance, cost-effectiveness and cost-utility as well as assessment of participants' attitudes towards and experience with the described two-step screening programme. The study is endpoint driven; participants are included in a 1:1 manner until 1200-1500 participants are treated for osteoporosis.