SAN ANTONIO, Dec. 15 /PRNewswire/ -- Denosumab is a new drug being studied
to prevent fractures in breast cancer patients receiving hormonal therapy.
Results of a phase 3 clinical trial using denosumab were presented Friday
evening at the San Antonio Breast Cancer Symposium by Georgiana Ellis, MD,
from the Seattle Cancer Care Alliance.
Denosumab is a highly specific antibody that interrupts the development of
osteoclasts -- specialized cells that break down bone. Because it is highly
specific, the chance of systemic effects in other parts of the body is low, so
patients do not need routine laboratory monitoring.
A group of drugs called aromatase inhibitors is used to prevent the
recurrence of breast cancer in postmenopausal women. These drugs are very
effective, but commonly associated with loss of bone density and an increased
risk of fractures.
To test the effectiveness of denosumab in preventing bone loss caused by
aromatase inhibitors, a clinical trial recruited 252 patients who had been
treated for early stage breast cancer and for whom treatment with anastrozole,
an aromatase inhibitor, was planned. Half of the patients were given
denosumab, while the other half was not. All patients were instructed to take
daily doses of calcium and vitamin D.
The study lasted for 2 years, with patients receiving an injection of
denosumab every 6 months. All the women from both groups had their lumbar
spine bone density measured at the end of the first and second years. By the
end of the first year, the bone density of the women receiving denosumab had
increased by nearly 5%, while the women who did not receive denosumab had bone
density decreases of almost 1%. By the end of the second year, the difference
was even greater: in the women receiving denosumab, bone density had increased
by almost 6%, while the bone density of the women who did not receive
denosumab decreased by nearly 2%. Similar effects on bone density were seen at
the hip and the wrist. Side effects of denosumab were similar to those
reported in the control group.
Denosumab appears to be a safe and effective treatment for preventing bone
loss in women taking aromatase inhibitors, offering an alternative to existing
therapies, such as oral or intravenous bisphosphonates.
SOURCE San Antonio Breast Cancer Symposium
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