Zoledronate and osteonecrosis of the jaw in osteoporosis: incidence and risk factors. Analysis of the French Pharmacovigilance Database
Authors' conclusion
In a real-life setting, our data confirm that zoledronate-associated BRONJ in osteoporosis is scarce, seeming slightly more common compared with oral bisphosphonates.
Study context
- Population
- Cases of bisphosphonate-related osteonecrosis of the jaw (BRONJ) in patients treated with bisphosphonates for osteoporosis, French pharmacovigilance database up to 2020
- Exposure
- Zoledronate vs oral bisphosphonates in osteoporosis
- Outcome
- Incidence of BRONJ
Methodological detailsreal-life setting, French pharmacovigilance database, Medic'AM database
- Real-life setting
- French pharmacovigilance database
- Medic'AM database
Main finding
As reported in the abstract
BRONJ incidence, 2011–2020
Zoledronate
9.6
/100,000 patient-year (PY)
Alendronate
5.1
/100,000 PY
Risedronate
2.0
/100,000 PY
Zoledronate vs Alendronate: P < 0.001 · Zoledronate vs Risedronate: P < 0.001
Observational data: associations, not effects.
Further findings
Number of patients treated with bisphosphonates over 10 years
- Steady decrease
- 44.5%
BRONJ incidence over time
- Incidence in 2011 (/100,000 PY)
- 5.8
- Incidence in 2020 (/100,000)
- 1.5
- BRONJ following denosumab in 2018 rebound
- 47.6%
- Rebound observed in 2018
Risk factors
- Recent dental cares in BRONJ
- more than 40%
- Zoledronate had a shorter exposure time than oral bisphosphonates
Original publication
Zoledronate and osteonecrosis of the jaw in osteoporosis: incidence and risk factors. Analysis of the French Pharmacovigilance Database. Joint Bone Spine. Published 2 June 2023. doi:10.
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