Continuous treatment with odanacatib for up to 8 years in postmenopausal women with low bone mineral density: a phase 2 study

Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
Rene RizzoliD Gurner

Abstract

The efficacy and safety of weekly oral odanacatib (ODN) 50 mg for up to 8 years were assessed in postmenopausal women with low bone mineral density (BMD). Treatment with ODN for up to 8 years resulted in continued or maintained increases in BMD at multiple sites and was well tolerated. ODN is a selective inhibitor of cathepsin K. In a 2-year phase 2b study (3/10/25/50 mg ODN once weekly [QW] or placebo) and extensions (50 mg ODN QW or placebo), ODN treatment for 5 years progressively increased BMD and decreased bone resorption markers in postmenopausal women with low BMD ( ClinicalTrials.gov NCT00112437). In this prespecified interim analysis at year 8 of an additional 5-year extension (years 6 to 10), patients (n = 117) received open-label ODN 50 mg QW plus weekly vitamin D3 (5600 IU) and calcium supplementation as needed. Primary end points were lumbar spine BMD and safety. Patients were grouped by ODN exposure duration. Mean (95 % confidence interval [CI]) lumbar spine BMD changes from baseline were 4.6 % (2.4, 6.7; 3-year continuous ODN exposure), 12.9 % (8.1, 17.7; 5 years), 12.8 % (10.0, 15.7; 6 years), and 14.8 % (11.0, 18.6; 8 years). Similar patterns of results were observed for BMD of trochanter, femoral neck, and tot...Continue Reading

References

Feb 15, 2001·JAMA : the Journal of the American Medical Association·UNKNOWN NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy
Feb 24, 2006·The New England Journal of Medicine·Michael R McClungUNKNOWN AMG 162 Bone Loss Study Group
Dec 6, 2006·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Russel BurgeAnna Tosteson
Jan 30, 2008·Bioorganic & Medicinal Chemistry Letters·Jacques Yves GauthierW Cameron Black
Apr 16, 2008·Journal of the American Academy of Dermatology·Anna PeroniGiampiero Girolomoni
Mar 12, 2010·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Ego SeemanJose Zanchetta
Aug 27, 2010·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·John A EismanAntonio Lombardi
Dec 15, 2010·Bone·Roland BaronR Graham G Russell
Apr 1, 2011·Lancet·Tilman D RachnerLorenz C Hofbauer
May 17, 2011·Journal of the American Academy of Dermatology·Thomas M RüngerVanessa Smith
Nov 25, 2011·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Patricia J MasarachiaLe T Duong
Nov 25, 2011·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Tara CusickLe T Duong
May 11, 2012·The New England Journal of Medicine·Marcea WhitakerGeorge Benson
Jul 11, 2012·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Bente LangdahlAlbert Leung
Jul 28, 2012·The Annals of Pharmacotherapy·Emily E Sutton, Daniel M Riche
Oct 20, 2012·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·J A KanisUNKNOWN Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCE
Nov 28, 2012·The American Journal of Medicine·Michael McClungE Michael Lewiecki
Jan 23, 2013·The Journal of Clinical Endocrinology and Metabolism·Kim BrixenAnne E de Papp
Mar 5, 2014·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Brenda L PennypackerLe T Duong
Mar 20, 2014·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Angela M CheungAnne E de Papp
May 2, 2014·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·C E KawalilakS A Kontulainen
Jul 16, 2014·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·R RizzoliJ-Y Reginster
Feb 17, 2015·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Michael S OminskyDavid W Dempster
Jul 17, 2015·Journal of Orthopaedic Research : Official Publication of the Orthopaedic Research Society·Brenda L PennypackerLe Thi Duong

❮ Previous
Next ❯

Citations

Aug 16, 2016·Annals of the New York Academy of Sciences·Michael Pazianas, Bo Abrahamsen
Oct 21, 2016·Expert Opinion on Pharmacotherapy·M C van der GoesJ W Jacobs
Sep 30, 2016·Nature Reviews. Disease Primers·Richard EastellSteven R Cummings
Nov 5, 2016·American Journal of Medical Genetics. Part C, Seminars in Medical Genetics·Ronit MaromBrendan Lee
Jan 22, 2019·British Journal of Clinical Pharmacology·Julie A StoneS Aubrey Stoch
Mar 25, 2017·Frontiers in Endocrinology·Toshihiro Sugiyama, Hiromi Oda
Mar 9, 2017·Drugs·Edoardo MarraniRolando Cimaz
Mar 3, 2020·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Robert ReckerLe T Duong
Jan 26, 2020·Proceedings of the National Academy of Sciences of the United States of America·Meghan C Ferrall-FairbanksManu O Platt
Jul 11, 2020·Journal of Pharmacokinetics and Pharmacodynamics·Stefan ZajicJulie A Stone
Nov 18, 2020·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·N BinkleyA C Santora
Mar 17, 2021·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Socrates PapapoulosArthur Santora
Jan 1, 2020·Oral Science International·Maiko Omi, Yuji Mishina
Aug 10, 2021·Frontiers in Pharmacology·Shan-Shan LiDai-Feng Li

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