Nebenwirkungen · Prolia
Prolia 60 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8
HOS-122274 · Präparat HOS-095495
Osteonecrosis of the jaw ONJ has been reported rarely, in 18 patients, in clinical trials in osteoporosis and in breast or prostate cancer patients receiving hormone ablation including a total of 23 552 patients (see section 4.4). Thirteen of these ONJ cases occurred in postmenopausal women with osteoporosis during the phase III clinical trial extension following treatment with denosumab for up to 10 years. Incidence of ONJ was 0.04% at 3 years, 0.06% at 5 years and 0.44% at 10 years of denosumab treatment. The risk of ONJ increased with duration of exposure to denosumab.
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Version 2026-10-23T11:34:00Z · SHA-256 174c5535bb75755ca424fee3d85c7f49e9137f02bf7a7f9476e53617340257a2 · Passage 3c916773ae7287cddcf89d3b022be3f985a0de28960c250e10811d9d02cf7fb0 · Zeichen 5967–6545 im Abschnitt