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Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events

Journal article
Authors J. Acquavella
V. Ehrenstein
M. Schiodt
U. Heide-Jorgensen
A. Kjellman
S. Hansen
Cecilia Larsson Wexell
B. B. Herlofson
S. E. Noerholt
H. J. Ma
K. Öhrling
R. K. Hernandez
H. T. Sorensen
Published in Clinical Epidemiology
Volume 8
Pages 267-272
ISSN 1179-1349
Publication year 2016
Published at Institute of Clinical Sciences, Department of Biomaterials
Pages 267-272
Language en
Keywords cohort study, osteonecrosis of the jaw, pharmacovigilance, postmarketing drug surveillance, denosumab, zoledronic acid, danish national registry, surgeons position paper, bone metastases, american association, prostate-cancer, breast-cancer, outcomes, risk, denosumab, disease, Public, Environmental & Occupational Health
Subject categories Clinical Medicine


Objective: Osteonecrosis of the jaw (ONJ) is a recognized complication of potent antiresorptive therapies, especially at the doses indicated to prevent skeletal complications for cancer patients with bone metastases. This paper describes the rationale and methods for a prospective, post-authorization safety study of cancer patients treated with antiresorptive therapies. Methods: As part of a comprehensive pharmacovigilance plan, developed with regulators' input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab (120 mg subcutaneously) or zoledronic acid (4 mg intravenously, adjusted for renal function). Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Followup will extend from the first administration of antiresorptive treatment to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naive patients, zoledronic acid-naive patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly established national ONJ databases and adjudicated by the committee that functioned during the XGEVA (R) clinical trials program. Conclusion: This study will provide a real world counterpart to the clinical trial-estimated risks for ONJ and serious infections for cancer patients initiating denosumab or zoledronic acid. The establishment of ONJ databases in the three Scandinavian countries will have potential benefits outside this study for the elucidation of ONJ risk factors and the evaluation of ONJ treatment strategies.

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