| Amgen announces positive phase III data for denosumab | Posted on 03/04/2008 in Pharmaceutical Company Product News Amgen has announced the publication of pivotal phase III data for denosumab as a treatment in women with early and late-stage postmenopausal osteoporosis.
Presented in the Journal of Clinical Endocrinology and Metabolism, the trial showed that twice-yearly subcutaneous injections of the compound increased bone mineral density measured at all sites, including areas of the skeleton that are highly cortical.
The firm notes that cortical bone make sup three-quarters of skeletal mass in the body and is a key determinant of overall strength of the skeleton.
Denosumab was found to significantly increase lumbar spine, total hip and third-distal radius bone mineral density compared to placebo when measured at 24 months, while also increasing the total body figure.
Javier San Martin, global development lead for the denosumab osteoporosis program, said: "The effect of denosumab on wrist bone mineral density- reinforced by the bone mineral density increases at the total body and hip regions - suggests denosumab has a positive effect on highly cortical sites."
He added that it appears that the inhibition of RANK Ligand results in a potentially beneficial pattern of effects on cortical bone.
In January 2008, Amgen released clinical trial data showing that treatment with denosumab yielded greater bone mineral density gains than orally-administered alendronate.
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