Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD.

Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. Research Abstract Details 

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Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. Abstract Text:

E Michael Lewiecki,Paul D Miller,Michael R McClung,Stanley B Cohen,Michael A Bolognese,Yu Liu,Andrea Wang,Suresh Siddhanti,Lorraine A Fitzpatrick, ,E Michael Lewiecki,Paul D Miller,Michael R McClung,Stanley B Cohen,Michael A Bolognese,Yu Liu,Andrea Wang,Suresh Siddhanti,Lorraine A Fitzpatrick, ,E Michael Lewiecki,Paul D Miller,Michael R McClung,Stanley B Cohen,Michael A Bolognese,Yu Liu,Andrea Wang,Suresh Siddhanti,Lorraine A Fitzpatrick, ,

Denosumab is a monoclonal antibody to RANKL. In this randomized, placebo-controlled study of 412 postmenopausal women with low BMD, subcutaneous denosumab given every 3 or 6 mo was well tolerated, increased BMD, and decreased bone resorption markers for up to 24 mo. Continued study of denosumab is warranted in the treatment of low BMD in postmenopausal women. Introduction: Denosumab is a fully human monoclonal antibody that inhibits RANKL, a key mediator of osteoclastogenesis and bone remodeling. This prespecified exploratory analysis evaluated the efficacy and safety of denosumab through 24 mo in the treatment of postmenopausal women with low BMD. Materials and Methods: Four hundred twelve postmenopausal women with lumbar spine BMD T-scores of -1.8 to -4.0 or femoral neck/total hip T-scores of -1.8 to -3.5 were randomly assigned to receive double-blind, subcutaneous injections of placebo; denosumab 6, 14, or 30 mg every 3 mo; denosumab 14, 60, 100, or 210 mg every 6 mo; or open-label oral alendronate 70 mg once weekly. Outcome measures included BMD at the lumbar spine, total hip, distal one-third radius, and total body; bone turnover markers; and safety. Results: Denosumab increased BMD at all measured skeletal sites and decreased concentrations of bone turnover markers compared with placebo at 24 mo. At the lumbar spine, BMD increases with denosumab ranged from 4.13% to 8.89%. BMD changes with denosumab 30 mg every 3 mo and >/=60 mg every 6 mo were similar to, or in some cases greater than, with alendronate. The incidence of adverse events was similar in the placebo, denosumab, and alendronate treatment groups. Exposure-adjusted adverse events over 2 yr of treatment were similar to those reported during the first year of treatment. Conclusions: In these postmenopausal women with low BMD, treatment with denosumab for 2 yr was associated with sustained increases in BMD and reductions in bone resorption markers compared with placebo.

Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. Publishing Authors By Initials

EM Lewiecki,PD Miller,MR McClung,SB Cohen,MA Bolognese,Y Liu,A Wang,S Siddhanti,LA Fitzpatrick, ,EM Lewiecki,PD Miller,MR McClung,SB Cohen,MA Bolognese,Y Liu,A Wang,S Siddhanti,LA Fitzpatrick, ,EM Lewiecki,PD Miller,MR McClung,SB Cohen,MA Bolognese,Y Liu,A Wang,S Siddhanti,LA Fitzpatrick, ,

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Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Journal of bone and mineral research : the officia

VOLUME: 22

Page Numbers: 1832-41

Journal Abbreviation: J. Bone Miner. Res.

ISSN: 0884-0431

DAY: 17

MONTH: Dec

YEAR: 2007

Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. Information

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LANGUAGE: eng

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