Abstract
ObjectivesWhile risk factors of bisphosphonate (BP) associated osteonecrosis of the jaw have been properly analyzed, studies focusing on risk factors associated with denosumab (DNO) are sparse. The purpose of this study was to identify risk factors influencing the onset of medication-related osteonecrosis of the jaw (MRONJ) in patients receiving antiresorptive treatment (ART) with DNO by comparing patients suffering from MRONJ and patients without MRONJ. Multiple variables were evaluated including the impact of a previous BP intake.Materials and methodsA retrospective single-center cohort study with patients receiving DNO was conducted. One-hundred twenty-eight patients were included and divided into three groups: I (control, n = 40) receiving DNO with absence of MRONJ; group II (Test 1, n = 46), receiving DNO with presence of MRONJ; and group III (Test 2, n = 42) sequentially receiving BP and DNO with presence of MRONJ. Patients’ medical history, focusing on the identification of MRONJ risk factors, was collected and evaluated. Parameters were sex, age, smoking habit, alcohol consumption, underlying disease (cancer type, osteoporosis), internal diseases, additional chemo/hormonal therapy, oral inflammation, and trauma.ResultsThe following risk factors were identified to increase MRONJ onset significantly in patients treated with DNO: chemo/hormonal therapy (p = 0.02), DNO dosage (p < 0.01), breast cancer (p = 0.03), intake of corticosteroids (p = 0.04), hypertension (p = 0.02), diabetes mellitus (p = 0.04), periodontal disease (p = 0.03), apical ostitis (p = 0.02), and denture use (p = 0.02). A medication switch did not affect MRONJ development (p = 0.86).ConclusionsMalignant diseases, additional chemotherapy, DNO dosage, and oral inflammations as well as diabetes mellitus and hypertension influence MRONJ onset in patients treated with DNO significantly.Clinical relevancePatients receiving ART with DNO featuring aforementioned risk factors have a higher risk of MRONJ onset. These patients need a sound and regular prophylaxis in order to prevent the onset of MRONJ under DNO treatment.
Highlights
Medication-associated osteonecrosis of the jaw (MRONJ) is a rare but severe adverse side effect of an antiresorptive therapy (ART)
Patients suffering from cancer (n = 86) as underlying disease showed a significantly higher presence of medication-related osteonecrosis of the jaw (MRONJ) (p < 0.01) compared to patients suffering from osteoporosis (n = 56)
The results of this study revealed that higher DNO dosage, additional chemotherapy, hormonal therapy and corticosteroid therapy, breast cancer as underlying disease, co-morbidities like hypertension and diabetes mellitus, periodontal disease and apical periodontitis, and the use of dentures elevate the risk of MRONJ onset in patients treated with DNO
Summary
Medication-associated osteonecrosis of the jaw (MRONJ) is a rare but severe adverse side effect of an antiresorptive therapy (ART). Increasing tumor incidences, longer patient survival, adjuvant antiresorptive therapy strategies, and rising numbers of first-line regimes for osteoporosis are turning MRONJ into a disease of increasing importance [6,7,8]. Both the pharmacological mechanisms and pharmacokinetics of BP and DNO are markedly different:. BP are admitted orally or intravenously and accumulate in bone by selectively binding to hydroxyapatite. DNO, in contrast, is a human monoclonal antibody that selectively binds to the RANK ligand, a key cytokine for the differentiation, maturation, and activation of osteoclasts. Admitted DNO is inactivated by the immune system within weeks as other allogenic antibodies and does not accumulate in the body
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