Prevention and treatment of oral adverse effects of antiresorptive medications for osteoporosis – A position paper of the Brazilian Society of Endocrinology and Metabolism (SBEM), Brazilian Society of Stomatology and Oral Pathology (Sobep), and Brazilian Association for Bone Evaluation and Osteometabolism (Abrasso)
Abstract:Antiresorptive therapy is the main form of prevention of osteoporotic or fragility fractures. Medicationrelated osteonecrosis of the jaw (MRONJ) is a relatively rare but severe adverse reaction to antiresorptive and antiangiogenic drugs. Physicians and dentists caring for patients taking these drugs and requiring invasive procedures face a difficult decision because of the potential risk of MRONJ. The aim of this study was to discuss the risk factors for the development of MRONJ and prevention of this complica… Show more
“…For ARONJ prevention, most authors agree that a perioperative antibiotic prophylaxis should be given when performing a tooth extraction [ 3 , 7 , 13 , 19 , 22 , 23 , 24 ]. In this case, the antibiotic administration starts prior to surgery and is prolonged after the intervention, usually until mucosal healing is completed [ 13 , 25 ]. However, there is great variation regarding recommendations for the choice, dosage schedule and particularly the duration of antibiotic prophylaxis in the literature [ 13 , 26 ].…”
Antiresorptive agent-related osteonecrosis of the jaw (ARONJ) is a dreaded complication in patients with compromised bone metabolism. The purpose of the present study was to examine the occurrence of ARONJ and its related factors among patients with a history of antiresorptive therapy undergoing tooth extraction using preventive protocols at a Swiss university clinic. Data were retrospectively pooled from health records of patients having received a surgical tooth extraction between January 2015 and April 2020 in the Clinic of Cranio-Maxillofacial and Oral surgery, University of Zurich. A total of 970 patients received an extraction with flap elevation or wound closure during this period. A total of 104 patients could be included in the study. Furthermore, variables including age, gender, smoking, risk profile, choice, indication and duration of antiresorptive therapy, number of extractions, extraction site, surgical technique, choice and duration of antibiotics as well as the presence of postoperative inflammatory complications were assessed. Overall, 4 patients developed ARONJ (incidence of 3.8%) after tooth extraction at the same location, without previous signs of osteonecrosis. Preventive methods included predominantly primary wound closure using a full thickness mucoperiosteal flap and prolonged perioperative antibiotic prophylaxis. In accordance with current literature, the applied protocol showed a reliable outcome in preventing ARONJ when a tooth extraction is required.
“…For ARONJ prevention, most authors agree that a perioperative antibiotic prophylaxis should be given when performing a tooth extraction [ 3 , 7 , 13 , 19 , 22 , 23 , 24 ]. In this case, the antibiotic administration starts prior to surgery and is prolonged after the intervention, usually until mucosal healing is completed [ 13 , 25 ]. However, there is great variation regarding recommendations for the choice, dosage schedule and particularly the duration of antibiotic prophylaxis in the literature [ 13 , 26 ].…”
Antiresorptive agent-related osteonecrosis of the jaw (ARONJ) is a dreaded complication in patients with compromised bone metabolism. The purpose of the present study was to examine the occurrence of ARONJ and its related factors among patients with a history of antiresorptive therapy undergoing tooth extraction using preventive protocols at a Swiss university clinic. Data were retrospectively pooled from health records of patients having received a surgical tooth extraction between January 2015 and April 2020 in the Clinic of Cranio-Maxillofacial and Oral surgery, University of Zurich. A total of 970 patients received an extraction with flap elevation or wound closure during this period. A total of 104 patients could be included in the study. Furthermore, variables including age, gender, smoking, risk profile, choice, indication and duration of antiresorptive therapy, number of extractions, extraction site, surgical technique, choice and duration of antibiotics as well as the presence of postoperative inflammatory complications were assessed. Overall, 4 patients developed ARONJ (incidence of 3.8%) after tooth extraction at the same location, without previous signs of osteonecrosis. Preventive methods included predominantly primary wound closure using a full thickness mucoperiosteal flap and prolonged perioperative antibiotic prophylaxis. In accordance with current literature, the applied protocol showed a reliable outcome in preventing ARONJ when a tooth extraction is required.
“…ONJ is a rare but serious complication of antiresorptive therapy, which can occur with either BPs or DMAb use. It is more commonly observed in patients with neoplasms treated with higher doses than used for osteoporosis ( 23 , 24 ). In the 10-year follow-up of the FREEDOM study and its extension, seven cases of ONJ occurred in the prolonged treatment group and six cases in the crossover group ( 5 ).…”
Section: Risks Associated With Denosumab Treatmentmentioning
confidence: 99%
“…It should be noted that in addition to the use of drugs, other factors can enhance the risk of ONJ, such as diabetes mellitus, rheumatoid arthritis, systemic arterial hypertension, smoking and poor oral health (dental infection, trauma, or invasive procedures). These other risk factors should always be considered by healthcare professionals, who should advise patients on oral hygiene ( 24 ). In patients who develop ONJ during therapy with BPs, 82% had a history of dental procedures prior to the injury ( 25 ).…”
Section: Risks Associated With Denosumab Treatmentmentioning
confidence: 99%
“…From these, 0.68% developed ONJ in comparison with 0.05% in those who did not have a dental procedure ( 26 ). The duration of antiresorptive therapy has also been reported as an additional risk factor for ONJ ( 5 , 24 ). However, it should be noted that there is no evidence that discontinuing antiresorptive drugs before dental procedures reduces the risk of ONJ ( 24 ).…”
Section: Risks Associated With Denosumab Treatmentmentioning
confidence: 99%
“…Epidemiological data on ONJ are difficult to obtain, given its low prevalence, together with limitations in sample size and study design ( 24 ). The risk of this complication occurring with DMAb was slightly higher than that observed with ZOL in patients with osteoporosis (0.04% and 0.5% in the 2 and 7-year extensions of FREEDOM, respectively ( 3 , 5 ), vs. 0.017% ( 27 ) with ZOL).…”
Section: Risks Associated With Denosumab Treatmentmentioning
Denosumab (DMAb) is a human monoclonal antibody used as an antiresorptive drug in the treatment of osteoporosis. Approval at a dosage of 60 mg every 6 months was based on the results of the randomized, placebo-controlled trial (FREEDOM). The design of this 3-year study included an extension for up to 10 years. Those who were randomized to DMAb continued on drug, while those who were randomized to placebo transitioned to DMAb. The 10-year experience with DMAb provides data on efficacy of drug in terms of reduced fractures and continued increases in bone mineral density (BMD). The 10-year experience with denosumab also provides information about rare complications associated with the use of DMAb, such as osteonecrosis of the jaw (ONJ), and atypical femoral fractures (AFF). This experience provided new insights into the reversibility of effects upon discontinuation without follow-on therapy with another agent. This review focuses upon prolonged treatment with DMAb, with regard to beneficial effects on fracture reduction and safety. Additionally, its use in patients with impaired renal function, compare its results with those of bisphosphonates (BPs), the occurrence/frequency of complications, in addition to the use of different tools, from imaging techniques to histological findings, to evaluate its effects on bone tissue.
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