Effect of a Fracture Liaison Service on the Rate of Subsequent Fracture Among Patients With a Fragility Fracture in the Norwegian Capture the Fracture Initiative (NoFRACT): A Trial Protocol

Camilla Andreasen, Lene B Solberg, Trude Basso, Tove T Borgen, Cecilie Dahl, Torbjørn Wisløff, Gunhild Hagen, Ellen M Apalset, Jan-Erik Gjertsen, Wender Figved, Lars M Hübschle, Jens M Stutzer, Jan Elvenes, Ragnar M Joakimsen, Unni Syversen, Erik F Eriksen, Lars Nordsletten, Frede Frihagen, Tone K Omsland, Åshild Bjørnerem, Camilla Andreasen, Lene B Solberg, Trude Basso, Tove T Borgen, Cecilie Dahl, Torbjørn Wisløff, Gunhild Hagen, Ellen M Apalset, Jan-Erik Gjertsen, Wender Figved, Lars M Hübschle, Jens M Stutzer, Jan Elvenes, Ragnar M Joakimsen, Unni Syversen, Erik F Eriksen, Lars Nordsletten, Frede Frihagen, Tone K Omsland, Åshild Bjørnerem

Abstract

Importance: Fragility fracture is a major health issue because of the accompanying morbidity, mortality, and financial cost. Despite the high cost to society and personal cost to affected individuals, secondary fracture prevention is suboptimal in Norway, mainly because most patients with osteoporotic fractures do not receive treatment with antiosteoporotic drugs after fracture repair.

Objectives: To improve secondary fracture prevention by introducing a standardized intervention program and to investigate the effect of the program on the rate of subsequent fractures.

Design, setting, and participants: Trial protocol of the Norwegian Capture the Fracture Initiative (NoFRACT), an ongoing, stepped wedge cluster randomized clinical trial in 7 hospitals in Norway. The participating hospitals were cluster randomized to an intervention starting date: May 1, 2015; September 1, 2015; and January 1, 2016. Follow-up is through December 31, 2019. The outcome data were merged from national registries of women and men 50 years and older with a recent fragility fracture treated at 1 of the 7 hospitals.

Discussion: The NoFRACT trial is intended to enroll 82 000 patients (intervention period, 26 000 patients; control period, 56 000 patients), of whom 23 578 are currently enrolled by January 2018. Interventions include a standardized program for identification, assessment, and treatment of osteoporosis in patients with a fragility fracture that is led by a trained coordinating nurse. The primary outcome is rate of subsequent fracture (per 10 000 person-years) based on national registry data. Outcomes before (2008-2015; control period) and after (2015-2019; intervention period) the intervention will be compared, and each hospital will act as its own control. Use of outcomes from national registry data means that all patients are included in the analysis regardless of whether they are exposed to the intervention (intention to treat). A sensitivity analysis with a transition window will be performed to mitigate possible within-cluster contamination.

Results: Results are planned to be disseminated through publications in peer-reviewed journals and presented at local, national, and international conferences.

Conclusions: By introducing a standardized intervention program for assessment and treatment of osteoporosis in patients with fragility fractures, we expect to document reduced rates of subsequent fractures and fracture-related mortality.

Trial registration: ClinicalTrials.gov Identifier: NCT02536898.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Wisløff reported personal fees from Biogen and Amgen. Ms Hagen reported other funding from Pfizer. Dr Figved reported personal fees from Zimmer Biomet and Ortomedic AS Norway. Dr Joakimsen reported fees for lectures held on topics other than osteoporosis and/or epidemiology of fractures paid by several stakeholders: universities and colleges, patient organizations, and pharmaceutical companies (AstraZeneca, NovoNordisk, and Eli Lilly and Company). Dr Syversen reported personal fees from Eli Lilly and Company, MSD, Amgen, and Nycomed. Dr Frihagen reported grants from Eli Lilly and Company, Takeda, and Amgen. No other disclosures were reported.

Figures

Figure 1.. Norwegian Capture the Fracture Initiative…
Figure 1.. Norwegian Capture the Fracture Initiative (NoFRACT) Stepped Wedge Cluster Randomized Clinical Trial Design
The 7 hospitals were randomized for the order of the starting dates and divided into 3 sequences. The intervention was introduced stepwise with 4-month intervals. The intervention period started on May 1, 2015, and will continue through December 31, 2018, with follow-up through December 31, 2019. The University Hospital of North Norway was scheduled to start on May 1, 2015, but was delayed for 5 months and started on October 1, 2015.
Figure 2.. Application of the Standardized Intervention…
Figure 2.. Application of the Standardized Intervention Program in the Norwegian Capture the Fracture Initiative (NoFRACT) Trial
AOD indicates antiosteoporosis drugs; BMD, bone mineral density; eGFR, estimated glomerular filtration rate; ICD-10, International Statistical Classification of Diseases and Related Health Problems, Tenth Revision; PTH, parathyroid hormone; and TSH, thyroid-stimulating hormone. aThe Fracture Risk Assessment Tool (FRAX) is used to calculate the 10-year probability of major osteoporotic fracture (score is given as a percentage; a higher percentage indicates higher probability of fracture).

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