OsteoporosisROSENCT01388244
Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
A study testing Screening in people with Osteoporosis, run by Odense University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35,000 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women
- Age 65-80 years
- Inhabitants of the Region of Southern Denmark
Who cannot join
- Self-reported use of antiosteoporotic treatment and a diagnose of osteoporosis
- Unability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Screening, Control
- Keywords
- Screening, Risk Assessment, Fractures, Absorptiometry, Photon, Fracture prevention, Women, Patient prespective
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Also called DXA scan
Screening by risk factor assessment (FRAX) followed by DXA
ControlOther
Observation by use of register data
| Study group | Role | What they receive |
|---|---|---|
| Screening | Active comparator | Two-step screening process using FRAX risk score assessment followed by DXA scanning for high risk participants. Receives: Other: Screening |
| Control | Other | Control arm - Fracture risk assessment by FRAX without any intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years follow-up on average
Secondary outcomes (1)
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
Measured: Three years follow-up on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, University Hospital Schleswig-Holstein
- Responsible party
- Principal investigator, Katrine Rubin, Odense University Hospital
- Investigators
- Kim Brixen, Professor, Study director, University og Southern Denmark, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388244
- Sponsor's protocol ID
- ROSE
- Other IDs
- S-20090127
- Acronym
- ROSE
- Status last verified
- Oct 2023
- First submitted
- 29 Jun 2011
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25578146Rubin 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.
PubMed 29218381Holmberg 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.
PubMed 30465216Hoiberg 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.
PubMed 30911782Rothmann 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.
PubMed 28875257Rothmann 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.
PubMed 25134980Rothmann 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.
PubMed 25361616Petersen 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.
PubMed 39992408Petersen 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.
PubMed 38638398Holmberg 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.
PubMed 26590810
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-stratified Osteoporosis Strategy Evaluation Study (ROSE)
- ClinicalTrials.gov ID
- NCT01388244
- Acronym / sponsor ID
- ROSE / ROSE
- Conditions
- Osteoporosis
- Keywords
- Screening, Risk Assessment, Fractures, Absorptiometry, Photon, Fracture prevention, Women, Patient prespective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35,000 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, University Hospital Schleswig-Holstein
- Study start
- Feb 2010 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | Active comparator | Other: ScreeningTwo-step screening process using FRAX risk score assessment followed by DXA scanning for high risk participants. |
| Control | Other | Other: ControlControl arm - Fracture risk assessment by FRAX without any intervention |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Women
- Age 65-80 years
- Inhabitants of the Region of Southern Denmark
Key exclusion criteria (2 listed)
- Self-reported use of antiosteoporotic treatment and a diagnose of osteoporosis
- Unability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningAlso: DXA scanScreening by risk factor assessment (FRAX) followed by DXA | Other | Screening |
| ControlObservation by use of register data | Other | Control |
Primary outcome
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
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.
1 secondary outcome
Cost-effectiveness / cost-utility of a two-step screening programme.
Time frame: Three years follow-up on average
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Results publication: PubMed 25578146Rubin 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.
- Results publication: PubMed 29218381Rubin 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.
- Results publication: PubMed 30465216Holmberg 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.
- Results publication: PubMed 30911782Hoiberg 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.
- Results publication: PubMed 28875257Rothmann 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.
- Results publication: PubMed 25134980Rothmann 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.
- Results publication: PubMed 25361616Rothmann 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.
- Derived from this study: PubMed 39992408Petersen 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.
- Derived from this study: PubMed 38638398Petersen 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.
- Derived from this study: PubMed 26590810Holmberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Brixen, Professor study director
University og Southern Denmark, Odense University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Osteoporosis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388244, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.