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Ten-year follow-up of fracture risk in a systematic population-based screening program : the risk-stratified osteoporosis strategy evaluation (ROSE) randomised trial

Petersen, Tanja Gram ; Abrahamsen, Bo ; Høiberg, Mikkel ; Rothmann, Mette Juel ; Holmberg, Teresa ; Gram, Jeppe ; Bech, Mickael ; Åkesson, Kristina E. LU ; Javaid, M. Kassim and Hermann, Anne Pernille , et al. (2024) In EClinicalMedicine 71.
Abstract

Background: Osteoporotic fractures pose a growing public health concern. Osteoporosis is underdiagnosed and undertreated, highlighting the necessity of systematic screening programs. We aimed to evaluate the effectiveness of a two-step population-based osteoporotic screening program. Methods: This ten-year follow-up of the Risk-stratified Osteoporosis Strategy Evaluation (ROSE) randomized trial tested the effectiveness of a screening program utilizing the Fracture Risk Assessment Tool (FRAX) for major osteoporotic fractures (MOF) to select women for dual-energy x-ray absorptiometry (DXA) scan following standard osteoporosis treatment. Women residing in the Region of Southern Denmark, aged 65–80, were randomised (single masked) into a... (More)

Background: Osteoporotic fractures pose a growing public health concern. Osteoporosis is underdiagnosed and undertreated, highlighting the necessity of systematic screening programs. We aimed to evaluate the effectiveness of a two-step population-based osteoporotic screening program. Methods: This ten-year follow-up of the Risk-stratified Osteoporosis Strategy Evaluation (ROSE) randomized trial tested the effectiveness of a screening program utilizing the Fracture Risk Assessment Tool (FRAX) for major osteoporotic fractures (MOF) to select women for dual-energy x-ray absorptiometry (DXA) scan following standard osteoporosis treatment. Women residing in the Region of Southern Denmark, aged 65–80, were randomised (single masked) into a screening or a control group by a computer program prior to inclusion and subsequently approached with a mailed questionnaire. Based on the questionnaire data, women in the screening group with a FRAX value ≥15% were invited for DXA scanning. The primary outcome was MOF derived from nationwide registers. ClinicalTrials.gov: NCT01388244, status: Completed. Findings: All randomised women were included February 4, 2010–January 8, 2011, the same day as approached to participate. During follow-up, 7355 MOFs were observed. No differences in incidences of MOF were identified, comparing the 17,072 women in the screening group with the 17,157 controls in the intention-to-treat analysis (IRR 1.01, 0.95; 1.06). However, per-protocol, women DXA-scanned exhibited a 14% lower incidence of MOF (IRR 0.86, 0.78; 0.94) than controls with a FRAX value ≥15%. Similar trends were observed for hip fractures, all fractures, and mortality. Interpretation: While the ROSE program had no overall effect on osteoporotic fracture incidence or mortality it showed a preventive effect for women at moderate to high risk who underwent DXA scans. Hence the overall effect might have been diluted by those who were not at an intervention level threshold risk or those who did not show up for DXA. Using self-administered questionnaires as screening tools may be inefficient for systematic screening due to the low and differential screening uptake. Funding: INTERREG and the Region of Southern Denmark.

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Contribution to journal
publication status
published
subject
keywords
Fracture, FRAX, Osteoporosis, Population-based screening, Prevention
in
EClinicalMedicine
volume
71
article number
102584
publisher
Lancet Publishing Group
external identifiers
  • pmid:38638398
  • scopus:85189978140
ISSN
2589-5370
DOI
10.1016/j.eclinm.2024.102584
language
English
LU publication?
yes
id
0edd79b2-c275-40cb-b59c-43dfe80e4a05
date added to LUP
2024-04-25 10:15:19
date last changed
2024-06-20 15:24:56
@article{0edd79b2-c275-40cb-b59c-43dfe80e4a05,
  abstract     = {{<p>Background: Osteoporotic fractures pose a growing public health concern. Osteoporosis is underdiagnosed and undertreated, highlighting the necessity of systematic screening programs. We aimed to evaluate the effectiveness of a two-step population-based osteoporotic screening program. Methods: This ten-year follow-up of the Risk-stratified Osteoporosis Strategy Evaluation (ROSE) randomized trial tested the effectiveness of a screening program utilizing the Fracture Risk Assessment Tool (FRAX) for major osteoporotic fractures (MOF) to select women for dual-energy x-ray absorptiometry (DXA) scan following standard osteoporosis treatment. Women residing in the Region of Southern Denmark, aged 65–80, were randomised (single masked) into a screening or a control group by a computer program prior to inclusion and subsequently approached with a mailed questionnaire. Based on the questionnaire data, women in the screening group with a FRAX value ≥15% were invited for DXA scanning. The primary outcome was MOF derived from nationwide registers. ClinicalTrials.gov: NCT01388244, status: Completed. Findings: All randomised women were included February 4, 2010–January 8, 2011, the same day as approached to participate. During follow-up, 7355 MOFs were observed. No differences in incidences of MOF were identified, comparing the 17,072 women in the screening group with the 17,157 controls in the intention-to-treat analysis (IRR 1.01, 0.95; 1.06). However, per-protocol, women DXA-scanned exhibited a 14% lower incidence of MOF (IRR 0.86, 0.78; 0.94) than controls with a FRAX value ≥15%. Similar trends were observed for hip fractures, all fractures, and mortality. Interpretation: While the ROSE program had no overall effect on osteoporotic fracture incidence or mortality it showed a preventive effect for women at moderate to high risk who underwent DXA scans. Hence the overall effect might have been diluted by those who were not at an intervention level threshold risk or those who did not show up for DXA. Using self-administered questionnaires as screening tools may be inefficient for systematic screening due to the low and differential screening uptake. Funding: INTERREG and the Region of Southern Denmark.</p>}},
  author       = {{Petersen, Tanja Gram and Abrahamsen, Bo and Høiberg, Mikkel and Rothmann, Mette Juel and Holmberg, Teresa and Gram, Jeppe and Bech, Mickael and Åkesson, Kristina E. and Javaid, M. Kassim and Hermann, Anne Pernille and Rubin, Katrine Hass}},
  issn         = {{2589-5370}},
  keywords     = {{Fracture; FRAX; Osteoporosis; Population-based screening; Prevention}},
  language     = {{eng}},
  publisher    = {{Lancet Publishing Group}},
  series       = {{EClinicalMedicine}},
  title        = {{Ten-year follow-up of fracture risk in a systematic population-based screening program : the risk-stratified osteoporosis strategy evaluation (ROSE) randomised trial}},
  url          = {{http://dx.doi.org/10.1016/j.eclinm.2024.102584}},
  doi          = {{10.1016/j.eclinm.2024.102584}},
  volume       = {{71}},
  year         = {{2024}},
}