September 8, 2010
Amgen Canada today announced that Health Canada has approved
Prolia™ (denosumab) as another treatment choice for osteoporosis patients. Prolia is approved for the
treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of
osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant of other
available osteoporosis therapy. Prolia is an anti-resorptive therapy that inhibits the development and
activation of osteoclasts (the cells that eat away bone), while increasing bone mass and bone strength. As a
result, the chance of breaking bones (fracture) at the hip, spine and non-spine sites is reduced.
“Unlike any other treatment, Prolia decreases the formation of
bone removing cells, preventing bone loss and increasing bone mass, offering Canadian women a new choice for
preventing fracture,” said Dr. Aliya Khan, Professor of Clinical Medicine, Divisions Endocrinology and
Geriatrics at McMaster University.
Prolia is now available to patients in Canada with a prescription
from a physician and is administered in a 60 mg dose by a trained healthcare professional once every six
months as an injection under the skin.
Clinical Trial Results
Health Canada’s approval of Prolia is based on a study involving 7,808 postmenopausal women with
osteoporosis. In this study comparing Prolia to placebo, treatment with Prolia resulted in greater bone mass,
stronger bones, and significant reduced risk for fractures at the spine, hip and other sites measured at
three years.1 Specifically, Prolia demonstrated (relative to placebo):
- 68% reduction in incidence of vertebral (spine) fractures
- 40% reduction in incidence of hip fractures
- 20% reduction in incidence of non-vertebral (non-spine)
fractures
- Significant bone mineral density increases at all sites measured
(8.8 per cent at the lumbar spine, 6.4 per cent at the total hip, and 5.2 per cent at the femoral
neck).2
Safety Information
The most common side effects of Prolia as seen in the clinical trial were pain in the muscles, arms,
legs or back and a skin condition with itching, redness and/or dryness. Osteonecrosis of the jaw (ONJ) has
been reported in patients treated with denosumab or bisphosphonates. A dental examination with appropriate
preventative dentistry should be considered in patients with risk factors for ONJ. Prolia is contraindicated
for patients who are hypersensitive to the drug or any component of the product and those with hypocalcemia
(low blood levels of calcium). Adequate intake of calcium and vitamin D is important in all patients.
References:
1. Cummings SR et al. Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis. N
Engl J Med. 2009; 361(8):756-65.
2. Prolia™ Product Monograph. Amgen Canada Inc. August 2010, page 23.
