Zoledronate and osteonecrosis of the jaw in osteoporosis: incidence and risk factors. Analysis of the French Pharmacovigilance Database
•The estimated incidence of zoledronate-related osteonecrosis of the jaw is low in osteoporosis: 9.6/100,000 patient-year, but higher than oral bisphosphonates.•We observed a 74% decrease in the estimated incidence of BRONJ between 2011 and 2020, possibly related to the release of guidelines for den...
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| Published in: | Joint, bone, spine : revue du rhumatisme Vol. 90; no. 6; p. 105599 |
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| Main Authors: | , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
France
Elsevier Masson SAS
01-12-2023
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | •The estimated incidence of zoledronate-related osteonecrosis of the jaw is low in osteoporosis: 9.6/100,000 patient-year, but higher than oral bisphosphonates.•We observed a 74% decrease in the estimated incidence of BRONJ between 2011 and 2020, possibly related to the release of guidelines for dental health in patients treated by bisphosphonates.•The mean duration of exposure to zoledronate-rheumatology in the patients who developed a BRONJ is significantly shorter as compared to oral bisphosphonates.•Invasive dental care and pre-exposure to denosumab appears important risk factors of bisphosphonate-related osteonecrosis of the jaw.•We observed a 44.5% decrease in the number of patients treated by bisphosphonates for osteoporosis over this 10-year period.
Bisphosphonate-related osteonecrosis of the jaw (BRONJ) have been characterized with the use of oral bisphosphonates in osteoporosis and zoledronate in oncology. Uncertainties remain, though, with the occurrence of BRONJ related to the use of zoledronate in osteoporosis.
We aimed to estimate the incidence and characterize the risk factors of zoledronate-associated BRONJ in osteoporosis as compared with oral bisphosphonates in real life setting.
Cases of BRONJ associated with zoledronate, alendronate or risedronate were extracted from the French pharmacovigilance database up to 2020. The incidence of BRONJ was estimated as their respective numbers related to cases of BRONJ in patients treated with bisphosphonates for osteoporosis, over the same period, according to the Medic’AM database.
Between 2011 and 2020, BRONJ incidence with zoledronate was 9.6/100,000 patient-year (PY), significantly higher than with alendronate (5.1/100,000 PY, P<0.001), and risedronate (2.0/100,000 PY, P<0.001). The number of patients treated with bisphosphonates has steadily decreased by 44.5% over 10 years. Meanwhile, the incidence of BRONJ decreased (5.8/100,000 PY in 2011; 1.5/100,000 in 2020), although a rebound was observed in 2018, including 47.6% of BRONJ following denosumab. Apart from classical risk factors, recent dental cares stood out in more than 40% of BRONJ, and zoledronate had a shorter exposure time than oral bisphosphonates.
In a real-life setting, our data confirm that zoledronate-associated BRONJ in osteoporosis is scarce, seeming slightly more common compared with oral bisphosphonates. We also raise awareness of dental care guidelines and greater vigilance when using bisphosphonates in patients with previous exposure to denosumab. |
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| Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| ISSN: | 1297-319X 1778-7254 |
| DOI: | 10.1016/j.jbspin.2023.105599 |