Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

Osteoporosis Clinical Trial

— ROSE  

Official title:

Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388244
• Other study ID #: ROSE
• Secondary ID: S-20090127
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: December 2021

Study information

• Verified date: October 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Screening
Screening by risk factor assessment (FRAX) followed by DXA
• Control
Observation by use of register data

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology, Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	University Hospital Schleswig-Holstein, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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- — View 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. 2 — View 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 (RO — View 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 — View 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/s00198-0 — View 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 — View 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 Strateg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Three years follow-up on average
Secondary	Cost-effectiveness / cost-utility of a two-step screening programme.	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	Three years follow-up on average