Clinical trial NCT01388244: Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
Official title: Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Screening
Risk Assessment
Fractures
Absorptiometry, Photon
Fracture prevention
Women
Patient prespective
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: University Hospital Schleswig-Holstein
First posted: 2011-07-06
Enrollment: 35000
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Women
* Age 65-80 years
* Inhabitants of the Region of Southern Denmark

Exclusion Criteria:

* Self-reported use of antiosteoporotic treatment and a diagnose of osteoporosis
* Unability to give informed consent

Primary outcomes:
measure: 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
timeFrame: Three years follow-up on average
Secondary outcomes:
measure: Cost-effectiveness / cost-utility of a two-step screening programme.
timeFrame: Three years follow-up on average
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Dept. of Endocrinology, Odense University Hospital
Study officials:
affiliation: University og Southern Denmark, Odense University Hospital, Denmark
name: Kim Brixen, Professor
role: STUDY_DIRECTOR
References:
citation: Rubin KH, Holmberg T, Rothmann MJ, Hoiberg M, Barkmann R, Gram J, Hermann AP, Bech M, Rasmussen O, Gluer CC, Brixen K. The risk-stratified osteoporosis strategy evaluation study (ROSE): a randomized prospective population-based study. Design and baseline characteristics. Calcif Tissue Int. 2015 Feb;96(2):167-79. doi: 10.1007/s00223-014-9950-8. Epub 2015 Jan 13.
citation: Rubin KH, Rothmann MJ, Holmberg T, Hoiberg M, Moller S, Barkmann R, Gluer CC, Hermann AP, Bech M, Gram J, Brixen K. Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study. Osteoporos Int. 2018 Mar;29(3):567-578. doi: 10.1007/s00198-017-4326-3. Epub 2017 Dec 7.
citation: Holmberg T, Moller S, Rothmann MJ, Gram J, Herman AP, Brixen K, Tolstrup JS, Hoiberg M, Bech M, Rubin KH. Socioeconomic status and risk of osteoporotic fractures and the use of DXA scans: data from the Danish population-based ROSE study. Osteoporos Int. 2019 Feb;30(2):343-353. doi: 10.1007/s00198-018-4768-2. Epub 2018 Nov 21.
citation: Hoiberg MP, Rubin KH, Holmberg T, Rothmann MJ, Moller S, Gram J, Bech M, Brixen K, Hermann AP. Use of antiosteoporotic medication in the Danish ROSE population-based screening study. Osteoporos Int. 2019 Jun;30(6):1223-1233. doi: 10.1007/s00198-019-04934-7. Epub 2019 Mar 26.
citation: Rothmann MJ, Moller S, Holmberg T, Hojberg M, Gram J, Bech M, Brixen K, Hermann AP, Gluer CC, Barkmann R, Rubin KH. Non-participation in systematic screening for osteoporosis-the ROSE trial. Osteoporos Int. 2017 Dec;28(12):3389-3399. doi: 10.1007/s00198-017-4205-y. Epub 2017 Sep 5.
citation: Rothmann MJ, Huniche L, Ammentorp J, Barkmann R, Gluer CC, Hermann AP. Women's perspectives and experiences on screening for osteoporosis (Risk-stratified Osteoporosis Strategy Evaluation, ROSE). Arch Osteoporos. 2014;9:192. doi: 10.1007/s11657-014-0192-1. Epub 2014 Aug 19.
citation: Rothmann MJ, Ammentorp J, Bech M, Gram J, Rasmussen OW, Barkmann R, Gluer CC, Hermann AP. Self-perceived facture risk: factors underlying women's perception of risk for osteoporotic fractures: the Risk-Stratified Osteoporosis Strategy Evaluation study (ROSE). Osteoporos Int. 2015 Feb;26(2):689-97. doi: 10.1007/s00198-014-2936-6. Epub 2014 Nov 1.
citation: Holmberg T, Bech M, Gram J, Hermann AP, Rubin KH, Brixen K. Point-of-Care Phalangeal Bone Mineral Density Measurement Can Reduce the Need of Dual-Energy X-Ray Absorptiometry Scanning in Danish Women at Risk of Fracture. Calcif Tissue Int. 2016 Mar;98(3):244-52. doi: 10.1007/s00223-015-0084-4. Epub 2015 Nov 21.