Denosumab: risk of hip fracture

2 April 2013

The MHRA has advised healthcare professionals to be vigilant when prescribing denosumab (Prolia) following rare reports of atypical femoral fracture in patients with postmenopausal osteoporosis.

Prolia (denosumab) is also indicated for bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures | SCIENCE PHOTO LIBRARY

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 (FREEDOM), 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 warning from the MHRA in June 2011 about the risk of atypical femoral fractures in patients receiving long-term bisphosphonates for osteopososis.

View Prolia drug record

Further information: Amgen

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