Patients should be advised to report any unusual thigh, hip or groin pain, and healthcare professionals should evaluate patients with these symptoms for an incomplete femoral fracture. The contralateral femur should also be assessed as atypical fractures are often bilateral. Discontinuation of denosumab should be considered whilst the patient is being evaluated and an individual risk/benefit anaysis should be performed.
In the ongoing open-label extension of the pivotal, phase III postmenopausal osteoporosis trial (), two cases of atypical femoral fractures have been reported in patients receiving denosumab 60mg for ≥2.5 years.
Fracture risk also applies to bisphosphonates
These new recommendations follow a similar from the MHRA in June 2011 about the risk of atypical femoral fractures in patients receiving long-term bisphosphonates for osteopososis.
Further information: Amgen