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
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
  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 September 18, 2014