Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01388244
First received: June 29, 2011
Last updated: April 23, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Osteoporosis
Other: Screening
Other: Observation

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


Estimated Enrollment: 30000
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
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 followed by DXA
Control
Control arm - Fracture risk assessment by FRAX without any intervention
Other: Observation
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.

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.

  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:

  • Current antiosteoporotic treatment
  • Unability to give informed consent
  Contacts and Locations
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
  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: April 23, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Mass Screening
Risk Assessment
Femoral Fractures
Absorptiometry, Photon

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

ClinicalTrials.gov processed this record on April 17, 2014