Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)

NCT01388244 | Completed DMC

• 2 other identifiers: ROSES-20090127
• Study Type: interventional
• Target: 35,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoporosis

Keywords

Screening; Risk Assessment; Fractures; Absorptiometry, Photon; Fracture prevention; Women; Patient prespective

Outcome Measures

Primary Outcomes (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

  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 Outcomes (1)

• Cost-effectiveness / cost-utility of a two-step screening programme.

  Three years follow-up on average

Study Arms (2)

Screening

ACTIVE COMPARATOR

Two-step screening process using FRAX risk score assessment followed by DXA scanning for high risk participants.

Other: Screening

Control

OTHER

Control arm - Fracture risk assessment by FRAX without any intervention

Other: Control

Interventions

Screening OTHER

Screening by risk factor assessment (FRAX) followed by DXA

Also known as: DXA scan

Screening

Control OTHER

Observation by use of register data

Control

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Women
• Age 65-80 years
• Inhabitants of the Region of Southern Denmark

You may not qualify if:

• Self-reported use of antiosteoporotic treatment and a diagnose of osteoporosis
• Unability to give informed consent

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• University Hospital Schleswig-Holstein: collaborator

Study Sites (1)

Dept. of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (10)

• 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 characteristics. Calcif Tissue Int. 2015 Feb;96(2):167-79. doi: 10.1007/s00223-014-9950-8. Epub 2015 Jan 13.

  PMID: 25578146 RESULT

• 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 Strategy Evaluation (ROSE) study. Osteoporos Int. 2018 Mar;29(3):567-578. doi: 10.1007/s00198-017-4326-3. Epub 2017 Dec 7.

  PMID: 29218381 RESULT

• 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. 2019 Feb;30(2):343-353. doi: 10.1007/s00198-018-4768-2. Epub 2018 Nov 21.

  PMID: 30465216 RESULT

• 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/s00198-019-04934-7. Epub 2019 Mar 26.

  PMID: 30911782 RESULT

• 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/s00198-017-4205-y. Epub 2017 Sep 5.

  PMID: 28875257 RESULT

• 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. Epub 2014 Aug 19.

  PMID: 25134980 RESULT

• 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 (ROSE). Osteoporos Int. 2015 Feb;26(2):689-97. doi: 10.1007/s00198-014-2936-6. Epub 2014 Nov 1.

  PMID: 25361616 RESULT

• Petersen TG, Rubin KH, Javaid MK, Hermann AP, Akesson KE, Abrahamsen B. Long-term adherence to anti-osteoporosis medication and determinants of adherence in the population-based screening trial ROSE. Osteoporos Int. 2025 Apr;36(4):695-706. doi: 10.1007/s00198-025-07436-x. Epub 2025 Feb 24.

  PMID: 39992408 DERIVED

• Petersen TG, Abrahamsen B, Hoiberg M, Rothmann MJ, Holmberg T, Gram J, Bech M, Akesson KE, Javaid MK, Hermann AP, Rubin KH. Ten-year follow-up of fracture risk in a systematic population-based screening program: the risk-stratified osteoporosis strategy evaluation (ROSE) randomised trial. EClinicalMedicine. 2024 Apr 11;71:102584. doi: 10.1016/j.eclinm.2024.102584. eCollection 2024 May.

  PMID: 38638398 DERIVED

• Holmberg T, Bech M, Gram J, Hermann AP, Rubin KH, Brixen K. Point-of-Care Phalangeal Bone Mineral Density Measurement Can Reduce the Need of Dual-Energy X-Ray Absorptiometry Scanning in Danish Women at Risk of Fracture. Calcif Tissue Int. 2016 Mar;98(3):244-52. doi: 10.1007/s00223-015-0084-4. Epub 2015 Nov 21.

  PMID: 26590810 DERIVED

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Interventions

Mass Screening; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Officials

• Kim Brixen, Professor

  University og Southern Denmark, Odense University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 6, 2011
• Study Start: February 1, 2010
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

DK (1)