Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Southern Denmark
University of Schleswig-Holstein
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01388244
First received: June 29, 2011
Last updated: October 23, 2014
Last verified: June 2011
  Purpose

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 Intervention
Osteoporosis
Other: Screening
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 35000
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   65 Years to 80 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 29, 2011
Last Updated: October 23, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on October 28, 2014