To systematically review the literature available on the use of Denosumab (Dmab) in osteoporosis and the risk of ONJ.
The studies retrieved by the above strategies were included if they met the following pre-established criteria. The patients studied had to be diagnosed of osteoporosis (all ages, both sexes), and they had to be taking Dmab. We measured the likelihood of having osteonecrosis of the jaw. We included in the search for systematic reviews randomised clinical trials (RCT) and cohort studies. We excluded articles on cancer or other disease other than osteoporosis, animal and basic science studies. There was no limitation with regard to the number of patients included in the studies. The bibliographic databases screened were Medline and Embase and the Cochrane. The searches were conducted with language restriction (English, French and Spanish).
We found 10 articles that were studied in detail because by title or abstract they seemed to be related to the study, or because they had no abstract to review. Finally, 2 studies were included (one of them by indirect search) (Table 1). One of the study included was case series and another was systematic review of cases and series of cases and their data retrieved. The quality level of the two articles was low. Related to the studies population, all patients had osteoporosis, mostly were women with mean ages around 50-78 years. All patients were treated with subcutaneous denosumab every 6 months.
Table 1: Main characteristics of the included studies. View Table 1
In these two studies, the incidence of ONJ was very low. Some systemic factors such as previous treatment with BPs or dental extractions are associated with the development of osteonecrosis of the jaws in patients treated with Dmab. Stage 1 of ONJ was the most common and conservative treatment was used with the healing of the lesions.
There are not enough studies that have evaluated the role of Dmab in the development of osteonecrosis (ONJ) of the jaws. Some systemic factors that have been associated with the development of ONJ are described in patients treated with Dmab, such as previous treatment with bisphosphonates or tooth extractions.