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Effect of denosumab on bone mineral density and biochemical markers of bone turnover: Six-year results of a phase 2 clinical trial
Miller, Paul D. Wagman, Rachel B. Peacock, Munro Lewiecki, E. Michael Bolognese, Michael A.
Miller, Paul D.
Wagman, Rachel B.
Peacock, Munro
Lewiecki, E. Michael
Bolognese, Michael A.
Abstract
Context: This is a study extension to evaluate the efficacy and safety of long-term treatment with denosumab in postmenopausal women with low bone mass. Objective: Our objective was to describe changes in bone mineral density (BMD) and bone turnover markers as well as safety with 6 yr of denosumab treatment. Design: We 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. Setting: This multicenter study was conducted at 23 U.S. centers. Patients:Of the 262 subjects who completed the parent study, 200 enrolled in the study extension and 178 (89%) completed the first 2 yr. Intervention: All subjects received denosumab 60 mg sc every 6 months. Main Outcome Measures: We 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. Results: Over 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. Conclusions: In this study, denosumab was well tolerated and effective through 6 yr of continuous treatment in postmenopausal women with low bone mass.
Keywords
Date
2011
Type
Journal article
Journal
The Journal of Clinical Endocrinology and Metabolism
Book
Volume
96
Issue
2
Page Range
394-402
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
File Access
Controlled