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Amgen Drug Improves Bone Density in Study

More data on a phase III study shows Denosumab outperforms Merck's Fosamax.


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on Wednesday released more data for its bone-drug Denosumab in a phase III, head-to-head study with


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The late-stage study, involving 1,189 postmenopausal women with low bone mineral density (BMD), compared twice-yearly subcutaneous injections of Denosumab to a weekly oral dose of Fosamax.

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The data, presented Wednesday at the European Symposium on Calcified Tissues (ECTS) annual meeting, showed that Denosumab increased BMD at the total hip -- the primary endpoint in the study -- by 3.5% compared with 2.5% in the Fosamax arm. The drug also resulted in BMD at different measures: the trochanter by 4.5% vs. 3.5%; one-third radius by 1.1% vs. 0.6%; lumbar spine by 5.3% vs. 4.2%; and femoral neck by 2.2% vs. 1.6% in the Fosamax arm.

Amgen reported in January that the study met the primary and secondary endpoints and that adverse events were comparable between the two arms.

The company reiterated Wednesday that the adverse events were similar between arms.

Earlier in May, Amgen said that in a different late-stage, 500-patient one-year study in postmenopausal women, Denosumab resulted in more BMD gain than Fosamax.

The Street expects data from the more-anticipated "Freedom" study in the second half of the year -- it's a three-year study that looks at Denosumab in terms of fractures.

Amgen will also present midstage data on Denosumab in cancer patients at the upcoming American Society of Clinical Oncology meeting this weekend.

Amgen shares closed up 66 cents, or 1.6%, at $43.04 on Tuesday.