A recent study conducted by the pharmaceutical company Amgen reveals that the drug denosumab significantly reduced new fractures and increased bone density among postmenopausal women with osteoporosis.
Osteoporosis is a disease that affects the bones, making them fragile, weak, and prone to fractures. Fractures related to osteoporosis typically occur in the hip, spine, and wrist. Osteoporosis is a major public health issue, affecting an estimated 44 million Americans and approximately 55% of people over the age of 50. Women are particularly vulnerable to osteoporosis as they may lose up to 20% of their bone mass in the five to seven years following menopause.
The current study was a phase III trial that included approximately 7,800 women with osteoporosis. Approximately half of the patients were treated with denosumab, an investigative agent that reduces cellular breakdown of bone, and half received placebo (inactive substitute).
• New fractures of the spine were significantly reduced among patients treated with denosumab compared to those who received placebo.
• The time to first fracture of the hip or areas other than the spine was also significantly reduced among women treated with denosumab.
• Bone mineral density was substantially increased among the denosumab group compared to the placebo group.
• Side effects were similar among both groups of patients.
The researchers concluded that denosumab appears to reduce the risk of spine fractures and improved bone density among postmenopausal women with osteoporosis.
Reference: Amgen. Amgen Announces Positive Top-Line Results for Denosumab Pivotal Postmenopausal Osteoporosis Trial. Available at: http://wwwext.amgen.com/media/media_pr_detail.jsp?releaseID=1179628. Accessed July 2008.