• Paul D Miller, Rachel B Wagman, Munro Peacock, E Michael Lewiecki, Michael A Bolognese, Richard L Weinstein, Beiying Ding, Javier San Martin, and Michael R McClung.
• Colorado Center for Bone Research, 3190 South Wadsworth Boulevard, Ste 250, Lakewood, Colorado 80227, USA. millerccbr@aol.com
• J. Clin. Endocrinol. Metab. 2011 Feb 1;96(2):394-402.

ContextThis is a study extension to evaluate the efficacy and safety of long-term treatment with denosumab in postmenopausal women with low bone mass.ObjectiveOur objective was to describe changes in bone mineral density (BMD) and bone turnover markers as well as safety with 6 yr of denosumab treatment.DesignWe conducted an ongoing 4-yr, open-label, single-arm, extension study of a dose-ranging phase 2 trial. This paper reports a 2-yr interim analysis representing up to 6 yr of continuous denosumab treatment.SettingThis multicenter study was conducted at 23 U.S. centers.PatientsOf the 262 subjects who completed the parent study, 200 enrolled in the study extension and 178 (89%) completed the first 2 yr.InterventionAll subjects received denosumab 60 mg sc every 6 months.Main Outcome MeasuresWe evaluated BMD at the lumbar spine, total hip, femoral neck, and one third radius; biochemical markers of bone turnover; and safety, reported as adverse events.ResultsOver a period of 6 yr, continuous treatment with denosumab resulted in progressive gains in BMD in postmenopausal women with low bone mass. Reduction in bone resorption was sustained over the course of continuous treatment. Independent of past treatment and discontinuation period, subjects demonstrated responsiveness to denosumab therapy as measured by BMD and bone turnover markers. The safety profile of denosumab did not change over time.ConclusionsIn this study, denosumab was well tolerated and effective through 6 yr of continuous treatment in postmenopausal women with low bone mass.

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