Methods: We conducted a two-arm randomised controlled trial in women aged 70 to 85 years comparing a screening programme using the FRAX risk assessment tool versus usual management. The primary outcome was the proportion of individuals experiencing one or more osteoporosis-related fractures over a five-year period. In the screening arm, treatment was recommended in women identified to be at high risk of hip fracture, according to the FRAX 10-year hip fracture probability. This study was registered on the ISRCTN registry (ISRCTN 55814835).
Findings: 12 483 eligible women, identified from primary care, participated in the trial. Of 6 233 randomised to screening, treatment was recommended in 898 (14·4%). Osteoporosis medication use was higher at the end of year one in the screening group compared to controls (15·3% vs 4·5%, respectively), with uptake particularly higher (78.3% at 6 months) in the screening high risk subgroup. Screening did not reduce the incidence of all osteoporosis-related fractures (hazard ratio: 0·94, p=0·178, 95% C.I.: 0·85 to 1·03), nor the overall incidence of all clinical fractures (hazard ratio: 0.94, p=0.183, 95% C.I. : 0.86 to 1.03) but there was strong evidence for a reduction in hip fractures, a pre-specified secondary outcome (hazard ratio : 0·72, p=0·002 95% C.I. : 0·59 to 0·89). There was no evidence of differences in mortality, anxiety levels or quality of life.
Interpretation: A systematic, community-based screening programme of fracture risk in older women in the UK is feasible. Whilst there was no reduction in overall fracture rate the intervention was effective in reducing hip fractures by an estimated 28%.