A recent study conducted by the pharmaceutical company Amgen reveals that the drug denosumab significantly increased bone mineral density among women with early- and late-stage postmenopausal 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.
In this current study, 332 patients were treated with either twice-yearly injections of denosumab or a placebo. The following was observed:
- Significant increases in lumbar bone mineral density were seen among women treated with denosumab compared with the placebo group (6.5% versus 0.6%).
- Bone mineral density was also substantially increased in the hip and wrist among the denosumab group.
- Overall, total body bone mineral density increased 2.4% with denosumab compared with 1.4% among women receiving placebo.
- Further analysis revealed that these results were not affected by the time since menopause.
- Researchers were encouraged to learn that not only did specific sites of bone mineral density improve, but the portion of the bone responsible for strength (cortical area of the skeleton) was also improved.
- Side effects were similar between the denosumab and placebo treatment groups. The most commonly reported side effects among both groups were joint pain, sore throat, and back pain.
- Serious side effects were reported in 11% of the denosumab group and among 5.5% of the treatment group. The increased number of serious side effects among the denosumab group was primarily due to the greater number of patients who received the denosumab injection while hospitalized for infections not related to denosumab treatment.
Amgen expects that the results of its larger study, which evaluated denosumab’s impact on the reduction of fracture risk among postmenopausal women with osteoporosis, will be available later this year.
Reference: Amgen. Pivotal Phase 3 data show denosumab increased bone density at multiple skeletal sites in early and later stage postmenopausal women. Available at: https://www.amgen.com/media/media_pr_detail.jsp?releaseID=1125003.
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