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Osteoporosis International
Published in: Osteoporosis International 2/2013

01-02-2013 | Original Article

Assessing the risk of osteonecrosis of the jaw due to bisphosphonate therapy in the secondary prevention of osteoporotic fractures

Authors: F. Lapi, F. Cipriani, A. P. Caputi, G. Corrao, A. Vaccheri, M. C. Sturkenboom, M. Di Bari, D. Gregori, F. Carle, T. Staniscia, A. Vestri, M. Brandi, V. Fusco, G. Campisi, G. Mazzaglia, on behalf of the Bisphosphonates Efficacy-Safety Tradeoff (BEST) study group

Published in: Osteoporosis International | Issue 2/2013

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Abstract

Summary

There is evidence that the use oral bisphosphonates can lead to osteronecrosis of the jaws (ONJ). Although the occurrence of ONJ appears rare among oral bisphosphonates (BPs) users, it is important to know that it exists and can be opportunely minimized.

Introduction

The purpose of this study is to evaluate the association between BPs prescribed for the secondary prevention of osteoporotic fractures and the occurrence of ONJ.

Methods

An Italian record linkage claims database with a target population of around 18 million individuals (6 million over 55 years of age) constituted the data source. We conducted a nested case–control study within a cohort of individuals aged 55+ years old, who were discharged from hospitals with a primary diagnosis of incident osteoporotic fracture. The date related to the discharge diagnosis of ONJ was the index date. Conditional logistic regression for matched data was fitted to estimate the odds ratio (OR) along with 95 % confidence intervals (95 % CI) for the likely association between use of BPs and the risk of ONJ.

Results

Any one of the 61 ascertained cases of ONJ (incidence rate, 36.6 per 100,000 person-years) was matched to 20 controls for a total of 1120 controls. When the exposure to BPs was modeled according to recency (i.e., exposure time window prior to the index date) of use, the adjusted OR (95 % CI) for current users was 2.8 (1.3–5.9) against never users. The cumulative use of BPs has shown to increase the incidence of ONJ among patients with primary osteoporotic fractures, although not statistically significant risk has been observed.

Conclusions

Although the risk of BP-related ONJ appears low in non-oncological indications, it is important to be aware that it exists and to know how it may be predicted and possibly minimized.
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Metadata
Title
Assessing the risk of osteonecrosis of the jaw due to bisphosphonate therapy in the secondary prevention of osteoporotic fractures
Authors
F. Lapi
F. Cipriani
A. P. Caputi
G. Corrao
A. Vaccheri
M. C. Sturkenboom
M. Di Bari
D. Gregori
F. Carle
T. Staniscia
A. Vestri
M. Brandi
V. Fusco
G. Campisi
G. Mazzaglia
on behalf of the Bisphosphonates Efficacy-Safety Tradeoff (BEST) study group
Publication date
01-02-2013
Publisher
Springer-Verlag
Published in
Osteoporosis International / Issue 2/2013
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI
https://doi.org/10.1007/s00198-012-2013-y

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