| Odanacatib in the treatment of postmenopausal women with low bone mineral density: Three-year continued therapy and resolution of effect. | |
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MedLine Citation:
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PMID: 20740685 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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The selective cathepsin K inhibitor odanacatib (ODN) progressively increased bone mineral density (BMD) and decreased bone-resorption markers during 2 years of treatment in postmenopausal women with low BMD. A 1-year extension study further assessed ODN efficacy and safety and the effects of discontinuing therapy. In the base study, postmenopausal women with BMD T-scores between -2.0 and -3.5 at the lumbar spine or femur received placebo or ODN 3, 10, 25, or 50 mg weekly. After 2 years, patients (n = 189) were rerandomized to ODN 50 mg weekly or placebo for an additional year. Endpoints included BMD at the lumbar spine (primary), total hip, and hip subregions; levels of bone turnover markers; and safety assessments. Continued treatment with 50 mg of ODN for 3 years produced significant increases from baseline and from year 2 in BMD at the spine (7.9% and 2.3%) and total hip (5.8% and 2.4%). Urine cross-linked N-telopeptide of type I collagen (NTx) remained suppressed at year 3 (-50.5%), but bone-specific alkaline phosphatase (BSAP) was relatively unchanged from baseline. Treatment discontinuation resulted in bone loss at all sites, but BMD remained at or above baseline. After ODN discontinuation at month 24, bone turnover markers increased transiently above baseline, but this increase largely resolved by month 36. There were similar overall adverse-event rates in both treatment groups. It is concluded that 3 years of ODN treatment resulted in progressive increases in BMD and was generally well tolerated. Bone-resorption markers remained suppressed, whereas bone-formation markers returned to near baseline. ODN effects were reversible: bone resorption increased transiently and BMD decreased following treatment discontinuation. © 2011 American Society for Bone and Mineral Research. |
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Authors:
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John A Eisman; Henry G Bone; David J Hosking; Michael R McClung; Ian R Reid; Rene Rizzoli; Heinrich Resch; Nadia Verbruggen; Carolyn M Hustad; Carolyn Dasilva; Romana Petrovic; Arthur C Santora; B Avery Ince; Antonio Lombardi |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research Volume: 26 ISSN: 1523-4681 ISO Abbreviation: J. Bone Miner. Res. Publication Date: 2011 Feb |
Date Detail:
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Created Date: 2011-01-21 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8610640 Medline TA: J Bone Miner Res Country: United States |
Other Details:
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Languages: eng Pagination: 242-51 Citation Subset: IM |
Copyright Information:
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Copyright © 2011 American Society for Bone and Mineral Research. |
Affiliation:
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Garvan Institute of Medical Research, St Vincent's Hospital, University of New South Wales, Sydney, NSW, Australia. j.eisman@garvan.org.au. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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