Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study

Rubin, Katrine Hass; Rothmann, Mette Juel; Holmberg, Teresa; Høiberg, Mikkel; Möller, Sören; Barkmann, Reinhard; Glüer, Claus‐C.; Hermann, Anne Pernille; Bech, Mickael; Gram, Jeppe; Brixen, Kim

doi:10.1007/s00198-017-4326-3

Cited by 79 publications

(98 citation statements)

References 28 publications

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“…The current findings were in line with the primary findings of the two previous randomized pragmatic screening trials for fracture prevention, the ROSE study and the SCOOP study. In the ROSE study (Denmark) that studied women aged 65 to 80 years, screening also did not statistically significantly reduce the incidence of the main outcome major osteoporotic fractures (HR = 0.91; 95% CI 0.83–1.01) . Furthermore, in the SCOOP study (UK), performed among women aged 70 to 85 years, screening did not statistically significantly reduce the incidence of the main outcome osteoporotic fractures (HR = 0.94; 95% CI 0.85–1.03) .…”

Section: Discussionmentioning

confidence: 92%

“…Moreover, in the ROSE and the SCOOP studies, a clinically relevant effect on these primary outcomes cannot be excluded. Importantly, in both the ROSE and SCOOP studies, a statistically significant reduction in hip fractures was observed, but we have some concerns about these significant secondary results of both the ROSE and SCOOP studies.…”

Section: Discussionmentioning

confidence: 93%

“…Osteoporotic fractures were defined as all fractures except for skull, finger, hand, toe, and foot fractures . Major osteoporotic fractures were defined as all hip, vertebral, wrist, and humerus fractures . Falls in the past year were self‐reported on the follow‐up questionnaires.…”

Section: Methodsmentioning

confidence: 99%

“…As effective anti‐osteoporosis medication is available, population screening for fracture prevention has come within reach. Screening in two recent randomized trials, the Risk‐Stratified Osteoporosis Strategy Evaluation (ROSE) study and the Screening in the Community to Reduce Fractures in Older Women (SCOOP) study, did not significantly reduce the incidence of (osteoporotic) fractures, but secondary analyses showed a reduction of hip fractures . The current randomized pragmatic study started in the same period as these studies and could provide a final answer as to whether screening for fracture prevention is effective.…”

Section: Introductionmentioning

confidence: 90%

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The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial

Merlijn

Swart

Schoor

et al. 2019

Journal of Bone and Mineral Research

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Population screening for fracture risk may reduce the fracture incidence. In this randomized pragmatic trial, the SALT Osteoporosis Study (SOS), we studied whether screening for fracture risk and subsequent treatment in primary care can reduce fractures compared with usual care. A total of 11,032 women aged 65 to 90 years with ≥1 clinical risk factor for fractures were individually randomized to screening (n = 5575) or usual care (n = 5457). Participants in the screening group underwent a screening program, including bone densitometry and vertebral fracture assessment. Participants with a high 10‐year fracture probability (FRAX) or a vertebral fracture were offered treatment with anti‐osteoporosis medication by their general practitioner. Incident fractures as reported by questionnaires were verified with medical records. Follow‐up was completed by 94% of the participants (mean follow‐up = 3.7 years). Of the 5575 participants in the screening group, 1417 (25.4%) had an indication for anti‐osteoporosis medication. Screening and subsequent treatment had no statistically significant effect on the primary outcome fracture (hazard ratio [HR] = 0.97; 95% confidence interval [CI] 0.87–1.08), nor on the secondary outcomes osteoporotic fractures (HR = 0.91; 95% CI 0.81–1.03), major osteoporotic fractures (HR = 0.91; 95% CI 0.80–1.04), hip fractures (HR = 0.91; 95% CI 0.71–1.15), falls (odds ratio [OR] = 0.91; 95% CI 0.72–1.15), or mortality (HR = 1.03; 95% CI 0.91–1.17). Post hoc explorative finding suggested that screening might be most effective after a recent fracture (HR = 0.65; 95% CI 0.44–0.96 for major osteoporotic fractures and HR = 0.38; 95% CI 0.18–0.79 for hip fractures). The results of this study might have been compromised by nonparticipation and medication nonadherence in the screening group. Overall, this study does not provide sufficient indications to consider screening for fracture prevention. However, we cannot exclude its clinical relevance to reduce (major) osteoporotic fractures and hip fractures because of the relatively small number of women with a treatment indication in the intervention group. © 2019 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 93%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 90%

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The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial

Merlijn

Swart

Schoor

et al. 2019

Journal of Bone and Mineral Research

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“…Although a 2% cut‐off for FREM would result in a large number of false‐positives, this would be acceptable in practice, as the next step would be more detailed screening (ie, by DXA scanning) and only possible treatment after that. As population‐based screening for osteoporosis has been suggested in Denmark, a screening program of only those with a FREM value above 2% would be feasible because it is a much smaller scale than a population screening . The most commonly used intervention threshold based on FRAX in a range of national guidelines is a 10‐year MOF risk of 20%, though the threshold is as low as 4% in some areas of the world .…”

Section: Discussionmentioning

confidence: 99%

A New Fracture Risk Assessment Tool (FREM) Based on Public Health Registries

Rubin

Möller

Holmberg

et al. 2018

Journal of Bone and Mineral Research

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Some conditions are already known to be associated with an increased risk of osteoporotic fractures. Other conditions may also be significant indicators of increased risk. The aim of the current study was to identify conditions for inclusion in a fracture prediction model (fracture risk evaluation model [FREM]) for automated case finding of high-risk individuals of hip or major osteoporotic fractures (MOFs). We included the total population of Denmark aged 45+ years (N = 2,495,339). All hospital diagnoses from 1998 to 2012 were used as possible conditions; the primary outcome was MOFs during 2013. Our cohort was split randomly 50/50 into a development and a validation dataset for deriving and validating the predictive model. We applied backward selection on ICD-10 codes (International Classification of Diseases and Related Health Problems, 10th Revision) by logistic regression to develop an age-adjusted and sex-stratified model. The FREM for MOFs included 38 and 43 risk factors for women and men, respectively. Testing FREM for MOFs in the validation cohort showed good accuracy; it produced receiver-operating characteristic (ROC) curves with an area under the ROC curve (AUC) of 0.750 (95% CI, 0.741 to 0.795) and 0.752 (95% CI, 0.743 to 0.761) for women and men, respectively. The FREM for hip fractures included 32 risk factors for both genders and showed an even higher accuracy in the validation cohort as AUCs of 0.874 (95% CI, 0.869 to 0.879) and 0.851 (95% CI, 0.841 to 0.861) for women and men were found, respectively. We have developed and tested a prediction model (FREM) for identifying men and women at high risk of MOFs or hip fractures by using solely existing administrative data. The FREM could be employed either at the point of care integrated into electronic patient record systems to alert physicians or deployed centrally in a national case-finding strategy where patients at high fracture risk could be invited to a focused DXA program. © 2018 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).

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Cost-effectiveness of Screening for Osteoporosis in Older Men With a History of Falls

Ito

2020

JAMA Netw Open

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Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study

Cited by 79 publications

References 28 publications

The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial

The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial

A New Fracture Risk Assessment Tool (FREM) Based on Public Health Registries

Cost-effectiveness of Screening for Osteoporosis in Older Men With a History of Falls

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