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J Bone Miner Res. 2019 Jun 20. doi: 10.1002/jbmr.3815. [Epub ahead of print]

The effect of a screening and treatment program for the prevention of fractures in older women: a randomized pragmatic trial.

Author information

1
Amsterdam UMC, Vrije Universiteit Amsterdam, General Practice and Elderly Care Medicine, Amsterdam Public Health research institute, Amsterdam, Netherlands.
2
Stichting Artsen Laboratorium en Trombosedienst, Koog aan de Zaan, Netherlands.
3
Amsterdam UMC, Vrije Universiteit Amsterdam, Epidemiology and Biostatistics, Amsterdam Public Health research institute, Amsterdam, Netherlands.
4
Jeroen Bosch Ziekenhuis, Department of Orthopaedics, 's-Hertogenbosch, Netherlands.
5
Amsterdam UMC, Vrije Universiteit Amsterdam, Internal Medicine, Endocrine Section, Amsterdam, Netherlands.

Abstract

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 to usual care. 11,032 women aged 65-90 years with ≥1 clinical risk factor for fractures were individually randomized to screening (n=5,575) or usual care (n=5,457). 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). 1,417 (25.4%) out of 5,575 participants in the screening group 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 (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 non-participation and medication non-adherence 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 due to the relative small number of women with a treatment indication in the intervention group. The study was registered at www.trialregister.nl (NTR2430). This article is protected by copyright. All rights reserved.

KEYWORDS:

Clinical trials; Fracture prevention; Fracture risk assessment; Screening

PMID:
31220365
DOI:
10.1002/jbmr.3815

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