Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
The Risk-stratified Osteoporosis Strategy Evaluation Study is a prospective, randomized, population-based study designed to test whether risk-stratified screening for osteoporosis in women aged 65-80 years is effective in preventing fractures.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
|Official Title:||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
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Two-step screening process using FRAX risk score assessment followed by DXA scanning for high risk participants.
Screening by risk factor assessment followed by DXA
Control arm - Fracture risk assessment by FRAX without any intervention
Observation by use of register data
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388244
|Dept. of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|