Testosterone treatment and the risk of osteonecrosis: a pharmacovigilance analysis in Vigibase

Purpose Recent reports have raised concerns about a potential risk of osteonecrosis associated with testosterone treatment (TT). The aim of this pharmacovigilance study was to assess the risk of reporting osteonecrosis associated with the use of TT compared with use of any other medication. Methods We performed a disproportionality analysis to investigate the risk of reporting osteonecrosis with TT using the WHO database VigiBase((R)). We estimated the reporting odds ratio (ROR) and 95% confidence interval (CI) of reporting osteonecrosis with use of TT vs all other drugs, and the adjusted ROR with use of TT vs use of drugs for benign prostatic hyperplasia (BPH). Results Among men at least 18 years of age between January 1, 2000, and December 31, 2019, we identified 3479 reports of osteonecrosis, 84 of which were associated with TT use, out of a total of 4,667,754 adverse event reports. Reports of osteonecrosis in TT users occurred with both transdermal and injectable forms, and the mean age at report was 55.4 years. TT use was associated with a greater risk of reporting osteonecrosis compared to all other drugs (ROR, 5.13; 95% CI, 4.13-6.37) and compared with use of drugs for BPH (ROR, 3.00; 95% CI, 2.08-4.30). Half of the osteonecrosis reports associated with TT indicated concomitant use of corticosteroids. Conclusion TT was associated with a greater risk of reports of osteonecrosis compared to use of any other drug and use of drugs for BPH. This signal should be confirmed in complementary studies.

Automated summary

Recent reports raised concerns about the potential risk of osteonecrosis associated with testosterone treatment (TT). This pharmacovigilance study aimed to assess the risk of reporting osteonecrosis with TT compared to other medications. The results showed that TT was associated with a greater risk of reporting osteonecrosis compared to all other drugs and drugs for BPH.