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Article History

Received: 11 February 2025

Accepted: 11 April 2025

First Online: 16 June 2025

Declarations

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: Rachel Weinrib, Joan Fortuny and David Martinez are full-time employees of RTI Health Solutions. Bianca Kollhorst and Ulrike Haug are employees of the Leibniz Institute for Prevention Research and Epidemiology—BIPS, Bremen, Germany, an independent nonprofit research organisation. Astrid Kousholt and Vera Ehrenstein are employees of Aarhus University and Aarhus University Hospital, which provide research services via institutional research grants to multiple public and private stakeholders, including regulators, governmental agencies, contract research organisations and pharmaceutical companies. Peter Iversen is a nuclear medicine specialist employed at Aarhus University Hospital and is responsible for treatment with radium-223 in the Nuclear Medicine Department. Jann Mortensen is a full-time employee of Rigshospitalet and is responsible for treatment with radium-223 in the Nuclear Medicine Department. Dianne Bosch received speaker honoraria from MSD. Malou Kuppen is a radiation oncologist in training at Maastro and a board member of the CAPRI Foundation. Federica Pisa and Zdravko Vassilev are employees of Bayer and hold shares and/or stock options in the company. This study adhered to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance code of conduct.

: This study was performed in accordance with the Declaration of Helsinki. In the Netherlands, the study protocol was approved by the Medical Research Ethics Committee Oost-Nederland (CMO 2020-6573); written informed consent was obtained by the treating physician from subjects who were alive, except for patients who were lost to follow-up (due to lack of up-to-date contact details), and involved consent for publication. For Germany, the Ethics Committee of the University of Bremen stated that studies based on the data source (German Pharmacoepidemiological Research Database [GePaRD]) are exempt from institutional review board review. Still, all involved health insurance providers (AOK Bremen/Bremerhaven, DAK-Gesundheit, Techniker Krankenkasse [TK], and hkk Krankenkasse) and their responsible authorities (the German Federal Office for Social Security [no. 116-8261-459/2019], and the Senator for Health, Women and Consumer Protection in Bremen [no. 500-006-110-81/2017-2-227]) approved the use of GePaRD data for this study; the responsible authorities approved the use of GePaRD data without informed consent, as informed consent was deemed to be unacceptable and to bias results (in alignment with §75 of the Code of Social Law X). In Denmark, the study received mandatory registration at Aarhus University (journal nr. KEA-2017-36/812) and medical chart abstraction was approved by treating hospitals (Aarhus University Hospital and Copenhagen Hospital) and the Scientific Ethics Committee in the Central Denmark Region [] (journal nr. 1-45-70-41-20); the ethical committee waived the informed consent requirement.