Pharmacokinetic evaluation of bazedoxifene for the treatment of osteoporosis

Bibliography

• Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726-33
   PubMed Web of Science ®Google Scholar
• Kanis JA, Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 2005;16(3):229-38
   PubMed Web of Science ®Google Scholar
• Gambacciani M, Vacca F. Postmenopausal osteoporosis and hormone replacement therapy. Minerva Med 2004;95:507-20
   PubMedGoogle Scholar
• National Osteoporosis Foundation. Clinician's guide to prevention and treatment of osteoporosis. 2010. Available from: http://www.nof.org/sites/default/files/pdfs/NOF_ClinicianGuide2009_v7.pdf
   Google Scholar
• MacLean C, Newberry S, Maglione M, et al. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med 2008;148:197-213
   PubMed Web of Science ®Google Scholar
• Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-33
   PubMed Web of Science ®Google Scholar
• Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291(14):1701-12
   PubMed Web of Science ®Google Scholar
• Hendrix SL, Wassertheil-Smoller S, Johnson KC, et al. Effects of conjugated equine estrogen on stroke in the Women's Health Initiative. Circulation 2006;113:2425-34
   PubMed Web of Science ®Google Scholar
• Lindsay R. Preventing osteoporosis with a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens (BZA/CE). Osteoporos Int 2011;22:447-51
   PubMed Web of Science ®Google Scholar
• National Osteoporosis Guideline Group Osteoporosis. Clinical guideline for prevention and treatment. Executive Summary. Updated July 2010
   Google Scholar
• Reginster JY. Antifracture efficacy of currently available therapies for postmenopausal osteoporosis. Drugs 2011;71(1):65-78
   PubMed Web of Science ®Google Scholar
• Shelly W, Draper MW, Krishnan V, et al. Selective estrogen receptor modulators: an update on recent clinical findings. Obstet Gynecol Survey 2008;63(3):163-81
   PubMed Web of Science ®Google Scholar
• Komm BS, Lyttle CR. Developing a SERM: stringent preclinical selection criteria leading to an acceptable candidate (WAY-140424) for clinical evaluation. Ann NY Acad Sci 2001;949:317-26
   PubMed Web of Science ®Google Scholar
• Arun B, Anthony M, Dunn B. The search for the ideal SERM. Expert Opin Pharmacother 2002;3:681-91
   PubMedGoogle Scholar
• Palacios S. Third generation SERMs: anything new? Maturitas 2010;67(2):101-2
   PubMed Web of Science ®Google Scholar
• Komm BS, Kharode YP, Bodine PV, et al. Bazedoxifene acetate: a selective estrogen receptor modulator with improved selectivity. Endocrinology 2005;146(9):3999-4008
   PubMed Web of Science ®Google Scholar
• Gruber C, Gruber D. Bazedoxifene. Curr Opin Investig Drugs 2004;5:1086-93
   PubMedGoogle Scholar
• Chandrasekaran A, Ermer J, McKeand W, et al. Bazedoxifene acetate metabolic disposition in healthy postmenopausal women. J Clin Pharmacol Ther 2003;73:47
   Web of Science ®Google Scholar
• Chandrasekaran A, McKeand WE, Sullivan P, et al. Metabolic disposition of [14C] bazedoxifene in healthy, postmenopausal women. Drug Metab Dispos 2009;37(6):1219-25
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment report for Conbriza [online]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_ _Public_assessment_report/human/000913/WC500033576.pdf
   Google Scholar
• Miller CP, Collini MD, Tran BD, et al. Design, synthesis, and preclinical characterization of novel, highly selective indole estrogens. J Med Chem 2001;44:1654-7
   PubMed Web of Science ®Google Scholar
• Ronkin S, Northington R, Baracat E, et al. Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women. Obstet Gynecol 2005;105:1397-404
   PubMed Web of Science ®Google Scholar
• Boudes P, Ronkin S, Korner P, et al. Effects of bazedoxifene TSE-424, a novel tissue selective estrogen receptor modulator SERM, on the incidence of breast pain. Osteoporos Int 2003;14(Suppl 7):S14
   Google Scholar
• Ronkin S, Baracat E, Roma L, et al. TSE-424, a novel tissue selective estrogen, reduces biochemical indices of bone metabolism in a dose related fashion. Endocrine Society program and abstracts of the 83rd Annual Meeting; 20 – 23 June 2001; Denver, CO, USA
   Google Scholar
• Miller PD, Chines AA, Christiansen C, et al. Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study. J Bone Miner Res 2008;23(4):525-35
   PubMed Web of Science ®Google Scholar
• Silverman SL, Christiansen C, Genant HK, et al. Efficacy of bazedoxifene in reducing new vertebral fracture risk in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial. J Bone Miner Res 2008;23(12):1923-34
   PubMed Web of Science ®Google Scholar
• Pinkerton JV, Archer DF, Utian WH, et al. Bazedoxifene effects on the reproductive tract in postmenopausal women at risk for osteoporosis. Menopause 2009;16(6):1102-8
   PubMed Web of Science ®Google Scholar
• Kanis JA, Johansson H, Oden A, McCloskey EV. Bazedoxifene reduces vertebral and clinical fractures in postmenopausal women at high risk assessed with FRAX. Bone 2009;44:1049-54
   PubMed Web of Science ®Google Scholar
• Kanis JA, Oden A, Johansson H, et al. FRAX® and its applications to clinical practice. Bone 2009;44:734-43
   PubMed Web of Science ®Google Scholar
• Silverman SL, Chines AA, Kendler DL, et al. Bazedoxifene Study Group. Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. Osteoporos Int 2012;23(1):351-63
   PubMed Web of Science ®Google Scholar
• Palacios S, Silverman S, Levine AB, et al. Long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: results of a 7-year, randomized, placebo-controlled study. Climacteric 2011;14(Suppl 1):59-60; Abs of oral presentation at 13th World Congress on the Menopause, Rome, Italy, 8-11 June 2011
   Google Scholar
• Archer DF, Pinkerton JV, Utian WH, et al. Bazedoxifene, a selective estrogen receptor modulator: effects on the endometrium, ovaries, and breast from a randomized controlled trial in osteoporotic postmenopausal women. Menopause 2009;16(6):1109-15
   PubMed Web of Science ®Google Scholar
• Harvey JA, Holm MK, Ranganath R, et al. The effects of bazedoxifene on mammographic breast density in postmenopausal women with osteoporosis. Menopause 2009;16:1193-6
   PubMed Web of Science ®Google Scholar
• Bachman G, Crosby U, Feldman RA, et al. Effects of bazedoxifene in nonflushing postmenopausal women: a randomized phase 2 trial. Menopause 2011;18(5):508-14
   PubMed Web of Science ®Google Scholar
• de Villiers TJ, Kendler D, Chines A, et al. Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled phase 3 trial. Osteoporos Int 2011;22:567-76
   PubMed Web of Science ®Google Scholar
• Crabtree JS, Peano BJ, Zhang X, et al. Activity of three selective estrogen receptor modulators on ormonedependent responses in the mouse uterus and mammary gland. Mol Cell Endocrinol 2008;287(1–2):40-6
   PubMed Web of Science ®Google Scholar
• Kharode Y, Bodine PV, Miller CP, et al. The pairing of a selective estrogen receptor modulator, bazedoxifene, with conjugated estrogens as a new paradigm for the treatment of menopausal symptoms and osteoporosis prevention. Endocrinology 2008;149(12):6084-91
   PubMed Web of Science ®Google Scholar
• Stefanick ML, Anderson GL, Margolis KL, et al. for the WHI Investigators. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 2006;295:1647-57
   PubMed Web of Science ®Google Scholar
• Lindsay R, Gallagher JC, Kagan R, et al. Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril 2009;92:1045-52
   PubMed Web of Science ®Google Scholar
• Pickar JH, Yeh IT, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril 2009;92:1018-24
   PubMed Web of Science ®Google Scholar
• Harvey JA, Pinkerton JV, Baracat EC, et al. Evaluation of changes in mammographic breast density associated with bazedoxifene/conjugated estrogens in postmenopausal women. Endocr Rev 2011;32(3):P1-P79
   Google Scholar
• Pinkerton JA, Constantine GD, Komm BS, et al. Breast effects of bazedoxifene/conjugated estrogens in a randomized, controlled trial of postmenopausal women [abstract P-46]. Poster presented at: the 19th Annual Meeting of the North American Menopause Society; 24 – 27 September 2008; Lake Buena Vista, FL, USA; 2008
   Google Scholar
• Pinkerton JV, Taylor H, Pan K, et al. Breast parameters with bazedoxifene/conjugated estrogens in randomized, controlled trials of postmenopausal women. Menopause 2010;17(6):1221-2
   Web of Science ®Google Scholar
• Pinkerton JV, Utian WH, Constantine GD, et al. Relief of vasomotor symptoms with the tissue-selective estrogen complex containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause 2009;16(6):1116-24
   PubMed Web of Science ®Google Scholar
• Lobo RA, Pinkerton JV, Gass ML, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril 2009;92(3):1025-38
   PubMed Web of Science ®Google Scholar
• Kagan R, Williams RS, Pan K, et al. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause 2010;17(2):281-9
   PubMed Web of Science ®Google Scholar
• Wells GA, Cranney A, Peterson J, et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2008(1):CD001155
   Google Scholar
• Wells G, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2008(1):CD004523
   Google Scholar
• Chesnut CHI, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004;19:1241-9
   PubMed Web of Science ®Google Scholar
• Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356:1809-22
   PubMed Web of Science ®Google Scholar
• Hochberg MC. Nonvertebral fracture risk reduction with nitrogen-containing bisphosphonates. Curr Osteoporos Rep 2008;6:89-94
   PubMedGoogle Scholar
• Harris ST, Blumentals WA, Miller PD. Ibandronate and the risk of non-vertebral and clinical fractures in women with postmenopausal osteoporosis: results of a meta-analysis of phase III studies. Curr Med Res Opin 2008;24:237-45
   PubMed Web of Science ®Google Scholar
• Rossini M, Bianchi G, Di Munno O, et al. Treatment of Osteoporosis in clinical Practice (TOP) Study Group. Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int 2006;17(6):914-21
   PubMed Web of Science ®Google Scholar
• Rossini M, Di Munno O, Gatti D, et al. Optimising bisphosphonate treatment outcomes in postmenopausal osteoporosis: review and Italian experience. Clin Exp Rheumatol 2011;29(4):728-35
   PubMed Web of Science ®Google Scholar
• Papapetrou PD. Bisphosphonate-associated adverse events. Hormones 2009;8(2):96-110
   PubMedGoogle Scholar
• Kennel KA, Drake MT. Adverse effects of bisphosphonates: implications for osteoporosis management. Mayo Clin Proc 2009;84(7):632-8
   PubMed Web of Science ®Google Scholar
• Ruggiero SL, Mehrotra B. Bisphosphonate-related osteonecrosis of the jaw: diagnosis, prevention, and management. Annu Rev Med 2009;60:85-96
   PubMed Web of Science ®Google Scholar
• Peano BJ, Crabtree JS, Komm BS, et al. Effects of various selective estrogen receptor modulators with or without conjugated estrogens on mouse mammary gland. Endocrinology 2009;150(4):1897-903
   PubMed Web of Science ®Google Scholar