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Denosumab raises bone mineral density in postmenopausal women.(Clinical Rounds)
The human monoclonal antibody denosumab has been found to increase bone mineral density in postmenopausal women, results of a recent randomized phase II study suggest.
Evaluation of the primary end point--the percentage change in lumbar spine bone mineral density (BMD) from baseline to 12 months--indicated that denosumab was active and significantly superior to placebo (N. Engl. J. Med. 2006;354:821-31).
Dr. Michael R. McClung, of the Providence Portland (Ore.) Medical Center, and his fellow researchers evaluated 12 months of denosumab, compared with open-label oral alendronate (70 mg once weekly) or placebo in postmenopausal women with low BMD, as defined by a "T score of -1.8 to -4.0 at the lumbar spine or -1.8 to -3.5 at either the femoral neck or total hip," the researchers said.
Subjects randomized to the experimental arm received denosumab every 3 months (6, 14, or 30 mg) or every 6 months (14, 60, 100, or 210 mg). Of the 412 participants, 319 women were randomized to the seven denosumab groups, 47 to the alendronate group, and 46 to the placebo group; 369 women completed the 12-month treatment study.
At study end, women receiving denosumab had increases in BMD at the lumbar spine of 3.0%-6.7%, compared with a 0.8% decrease with placebo, or a mean increase of 4.6% with alendronate. Bone mineral density was also found to be significantly superior with denosumab, compared with placebo at the total hip (mean change, 1.9%-3.6% vs. -0.6%, respectively), the distal third of the radius (0.4%-1.3% vs. -2.0%), and the total body (0.6%-2.8% vs. -0.2%), the researchers reported. They noted that "in exploratory comparisons, the observed mean changes in bone mineral density were at least as great with denosumab as with alendronate."
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Source: HighBeam Research, Denosumab raises bone mineral density in postmenopausal...