Denosumab (Bone Metabolism Regulator)
Denosumab is a new class of osteoporosis treatment called a human monoclonal antibody that prevents RANKL-RANK interaction and thereby inhibits osteoclast formation. Denosumab (Prolia™) is the first treatment approved by Health Canada in this class.
July 2019: Effective July 1, 2019, denosumab (Prolia®) has been added to the Nova Scotia Formulary for the treatment of osteoporosis in postmenopausal women and in men who meet the following criteria:
- Have a contraindication to oral bisphosphonates AND
- Are at high risk for fracture* OR have had a fragility fracture or a decline in bone mineral density despite being on other osteoporosis therapies for one year OR are intolerant to other available osteoporosis therapies.
*High fracture risk is defined as Moderate risk as defined by CAROC or FRAX plus a prior fragility fracture OR High risk as defined by CAROC or FRAX.
March 2018: Coverage for denosumab (Prolia®) under the following provincial drug benefits plans – Saskatchewan Formulary, New Brunswick Drug Plan Formulary, Ontario Drug Benefits Program and Alberta Health – has been expanded to include men. Coverage is now available for men who meet criteria similar to those for postmenopausal women: high fracture risk, contraindications to oral bisphosphonate use and failure on other osteoporosis therapies. In Saskatchewan, Prolia® is also covered for patients at moderate to high fracture risk who are one of the following: men on androgen deprivation therapy for prostate cancer or women on aromatase inhibitor therapy for breast cancer. Coverage for men was granted by BC Pharmacare in 2017.
Other Prolia® news: Health Canada has approved a new indication for denosumab (Prolia®): To increase bone mass for the treatment and prevention of glucocorticoid-induced osteoporosis in women and men at high risk of fracture.
How Does Denosumab Work?
Denosumab is an anti-resorptive therapy that inhibits the development and activation of osteoclasts (the cells that eat away bone).
How Effective Is It?
Denosumab reduces the risk of fractures at the spine, hip and other sites in women with postmenopausal osteoporosis.
Who Can Take It?
Denosumab can be used to reduce the risk of fractures in postmenopausal women with osteoporosis and in men with osteoporosis at high risk of fracture.
PROLIA is also indicated as a treatment to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture, and as a treatment to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy, who have low bone mass and are at high risk for fracture.
How Is It Taken?
Denosumab is administered as an injection under the skin, 60 mg/mL solution, by a trained healthcare professional twice yearly.
Are There Side Effects?
Side effects may include pain in the muscles, arms, legs or back and a skin condition with itching, redness and/or dryness. It also slightly increases the risk of cellulitis, a skin infection treated with antibiotics. In rare cases, osteonecrosis of the jaw has been reported in patients treated with denosumab.