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Submitted on December 21, 2007
Accepted on March 24, 2008
Michigan Bone and Mineral Clinic (H.G.B.), Detroit, Michigan 48236; The Bethesda Health Research Center (M.A.B.), Bethesda, MD 20817-1106; University of Manitoba (C.K.Y.), Winnipeg, Manitoba, Canada R3T 2N2; University of British Columbia (D.L.K.), Vancouver, BC, Canada V6T 1Z4; Amgen Inc. (H.W., Y.L., J.S.M.), Thousand Oaks, CA 91320-1799
* To whom correspondence should be addressed. E-mail: hgbone.md{at}att.net.
Context: Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor kappa B ligand (RANKL), a mediator of osteoclastogenesis and osteoclast survival.
Objective: This study evaluated the ability of denosumab to increase bone mineral density (BMD) and decrease bone turnover markers (BTMs) in early and later postmenopausal women with low BMD.
Design and Setting: This 2-year randomized, double-blind, placebo-controlled study was conducted in North America.
Participants: Subjects included 332 postmenopausal women with lumbar spine BMD T-scores between -1.0 and -2.5.
Interventions: Subjects were randomly assigned to receive denosumab subcutaneously, 60 mg every 6 months, or placebo. Randomization was stratified by time since onset of menopause (
5 years or > 5 years).
Main Outcome Measures: The primary endpoint was the percent change in lumbar spine BMD by dual-energy x-ray absorptiometry (DXA) at 24 months. Additional endpoints were percent change in volumetric BMD (vBMD) of the distal radius by quantitative computed tomography (QCT); percent change in BMD by DXA for the total hip, 1/3 radius, and total body; hip structural analysis (HSA); percent change in BTMs; and safety.
Results: Denosumab significantly increased lumbar spine BMD compared with placebo at 24 months (6.5% vs -0.6%; P<0.0001) with similar results for both strata. Denosumab also produced significant increases in BMD at the total hip, 1/3 radius, and total body (P<0.0001 vs placebo); increased distal radius vBMD (P<0.01); improved HSA parameters; and significantly suppressed serum CTX, TRAP-5b, and P1NP. The overall incidence of adverse events was similar between both study groups.
Conclusions: Twice-yearly denosumab increased BMD and decreased BTMs in early and later postmenopausal women.
This article has been cited by other articles:
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  E. M. Lewiecki Denosumab in postmenopausal osteoporosis: what the clinician needs to know Therapeutic Advances in Musculoskeletal Diseases, October 1, 2009; 1(1): 13 - 26. [Abstract] [PDF]
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 J. S Burkiewicz, S. L Scarpace, and S. P Bruce Denosumab in Osteoporosis and Oncology Ann. Pharmacother., September 1, 2009; 43(9): 1445 - 1455. [Abstract] [Full Text] [PDF]
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 S. R. Cummings, J. S. Martin, M. R. McClung, E. S. Siris, R. Eastell, I. R. Reid, P. Delmas, H. B. Zoog, M. Austin, A. Wang, et al. Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis N. Engl. J. Med., August 20, 2009; 361(8): 756 - 765. [Abstract] [Full Text] [PDF]
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