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Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE) (ROSE)

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ClinicalTrials.gov Identifier: NCT01388244
Recruitment Status : Active, not recruiting
First Posted : July 6, 2011
Last Update Posted : October 24, 2014
Sponsor:
Collaborators:
University of Southern Denmark
University of Schleswig-Holstein
Information provided by:
Odense University Hospital

Brief Summary:
The Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE) is a randomised population-based study, including 20,904 Danish women aged 65-81 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

Condition or disease Intervention/treatment Phase
Osteoporosis Other: Screening Other: Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
Study Start Date : January 2010
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Screening
Two-step screening process using FRAX risk score assessment followed by DXA scanning for high risk participants.
Other: Screening
Screening by risk factor assessment (FRAX) followed by DXA
Other Name: DXA scan

Control
Control arm - Fracture risk assessment by FRAX without any intervention
Other: Control
Observation by use of register data




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Cost-effectiveness / cost-utility of a two-step screening programme. [ Time Frame: Three years follow-up on average ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388244


Locations
Denmark
Dept. of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
University of Schleswig-Holstein
Investigators
Study Director: Kim Brixen, Professor University og Southern Denmark, Odense University Hospital, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Kim Brixen, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark
ClinicalTrials.gov Identifier: NCT01388244     History of Changes
Other Study ID Numbers: ROSE
S-20090127 ( Other Identifier: The Ethics Comittee of the Region of Southern Denmark )
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: June 2011

Keywords provided by Odense University Hospital:
Screening
Risk Assessment
Fractures
Absorptiometry, Photon
Fracture prevention
Women
Patient prespective

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases