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News Bulletin : ADA News Bulletin April 2011
22 APRIL 2011 Management of patients ON DENOSUMAB committee report Denosumab (pronounced Den-os-u -mab) or trade name Prolia is a fully human monoclonal antibody of the Ig G2 subclass possessing a high specificity and affinity for the human receptor of nuclear factor Kappa B (RANK) Ligand. In simple terms it is an anti-resorptive drug which inhibits formation, function and survival of osteoclasts. It has recently been approved in Australia for treatment of osteoporosis in postmenopausal women.1 Prior to its release it was extensively tested in a series of non clinical and clinical studies. It has been approved and is used in the United States of America, European Union, Canada and Switzerland. The regime for the treatment of postmenopausal osteoporosis is 60 mg/ml subcutaneous dose every six months.1 Although it is of a completely different mechanism, the end result on osteoclasts has some similarities to the bisphosphonates. There is a rapid reduction in the serum type 1C-telopeptide (CTX) within six hours of injection which shows some attenuation toward the end of a six month dosing cycle. In some patients the CTX falls to <150 pg/ml which is the threshold level at which osteonecrosis of the jaw (ONJ) may occur.2 The possibility of osteonecrosis of the jaw was specifically looked for in the extensive clinical studies prior to release. No cases were found. However, post-release two cases, one in the United States of America3 and one in the United Kingdom4, of Denosumab related ONJ have been reported, both in older medically compromised patients. Both of these cases were not being treated for osteoporosis, but for cancer. The prevalence of the risk is not known, but it is clearly low. No cases have been reported in Australia although the medication was released in December 2010. Hence, it is recommended that dentists should know that Denosumab, although not a bisphosphonate, may have a small risk of resulting in ONJ following bone invasive procedures such as tooth extraction. Patients prior to commencement of Denosumab therapy should be made dentally fit to minimise the risk of ONJ. Extractions in patients on Denosumab should be avoided if possible. The bone turnover status should be evaluated by a CTX Test and precautions similar to those recommended for patients on bisphosphonates followed. Patients on Denosumab with an exposed jaw bone should be promptly referred to an oral and maxillofacial surgeon. All cases of suspected Denosumab ONJ should be reported to the TGA (www.tga.gov.au/adr/bluecard.pdf). Alastair Goss On behalf of the Dental Therapeutics Committee firstname.lastname@example.org REfEREnCES References supplied by the author are available from email@example.com “...dentists should know that denosumab, although not a bisphosphonate, may have a small risk of resulting in OnJ following bone invasive procedures...”
ADA News Bulletin March 2011
ADA News Bulletin May 2011