New therapies for osteoporosis: Zoledronic acid, bazedoxifene, and denosumab
- Stuart L. Silverman
- … show all 1 hide
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
Intravenous (IV) zoledronic acid, a new once-yearly bisphosphonate therapy, is approved by the US Food and Drug Administration for treatment of postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, and osteoporosis in men. IV zoledronic acid significantly reduced the risk of vertebral, nonvertebral, and hip fractures in postmenopausal women and decreased risk of clinical fracture and clinical vertebral fracture in men and women with hip fracture. Two promising new therapies are in late clinical development. Denosumab is a monoclonal receptor activator of nuclear factor-κB ligand (RANKL) antibody given by subcutaneous injection every 6 months that has been shown to significantly reduce risk of vertebral-, nonvertebral-, and hip fracture in postmenopausal women. Bazedoxifene, an estrogen agonist/antagonist, has significantly reduced the risk of vertebral fracture in postmenopausal women; a post hoc analysis showed reduction in risk of nonvertebral fracture in high-risk women.
- Black, D.M., Delmas, P.D., Eastell, R. (2007) Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356: pp. 1809-1822 CrossRef
- Lyles, K.W., Colon-Emeric, C.S., Magaziner, J.S. (2007) HORIZON Recurrent Fracture Trial: Zoledronic acid in reducing clinical fracture and mortality after hip fracture. N Engl J Med 357: pp. 1799-1809 CrossRef
- Zoledronic acid prescribing information. Available at http://www.pharma.us.novartis.com/product/pi/pdf/reclast.pdf. Accessed June 5, 2009.
- McClung, M., Recker, R., Miller, P. (2007) Intravenous zoledronic acid 5 mg in the treatment of postmenopausal women with low bone density previously treated with alendronate. Bone 41: pp. 122-128 CrossRef
- Reid, D.M., Devogelaer, J.P., Saag, K. (2009) Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomized controlled trial. Lancet 373: pp. 1253-1263 CrossRef
- Ronkin, S., Northington, R., Baracat, E. (2005) Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator in postmenopausal women. Obstet Gynecol 105: pp. 1397-1404
- Duren, D., Ronkin, S., Pickar, J. (2006) Bazedoxifene combined with conjugated estrogens: a novel alternative to traditional hormone therapies [abstract]. Fertil Steril XX: pp. 88-S89 CrossRef
- Itabashi, I., Ohta, H., Ebede, B. (2008) A double-blind, placebocontrolled, dose-response study of bazedoxifene in Japanese postmenopausal women with osteoporosis [abstract]. J Bone Miner Res 23: pp. P79
- Bachmann, G., Crosby, U., Feldman, R.A. (2008) Vasomotor effects of bazedoxifene in non-flushing postmenopausal women [abstract P-10]. Menopause 15: pp. 1212
- Boudes, P., Ronkin, S., Korner, P. (2003) Effects of bazedoxifene (TSE-424), a novel tissue selective estrogen receptor modulator (SERM), on the incidence of breast pain [abstract]. Osteoporos Int 14: pp. 4
- Chestnut, C.H., Christiansen, C., Hoeck, H.C. (2007) Safety and tolerability of bazedoxifene for the prevention of postmenopausal osteoporosis [abstract]. J Bone Miner Res 22: pp. W387
- Miller, C.P., Christiansen, C., Hoeck, H.C. (2007) Efficacy of bazedoxifene for prevention of postmenopausal osteoporosis. Results of a 2-year, phase III, placebo and active-controlled study [abstract]. J Bone Miner Res 22: pp. 1209 CrossRef
- Miller, P.D., Chines, A.A., Christiansen, C. (2008) Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-year results of a randomized, double-blind, placebo-, and active-controlled study. J Bone Miner Res 23: pp. 525-535 CrossRef
- Silverman, S.L., Christiansen, C., Genant, H.K. (2008) 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 23: pp. 1923-1934 CrossRef
- Adachi, J.D., Chesnut, C.H., Brown, J.P. (2007) Safety and tolerability of bazedoxifene in postmenopausal women with osteoporosis: results from a 3-year, randomized, placebo-, and active-controlled clinical trial [abstract]. J Bone Miner Res 22: pp. W385 CrossRef
- Miller, P.D., Bolognese, M.A., Lewiecki, E.M. (2008) Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone 43: pp. 222-229 CrossRef
- Bekker, P.J., Holloway, D.L., Rasmussen, A.S. (2004) Single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res 19: pp. 1059-1066 CrossRef
- Cummings SR, McClung MR, Christiansen C, et al.: A phase III study of the effects of denosumab on vertebral, non-vertebral, and hip fractures: results from the freedom trial. J Bone Miner Res 2009 (in press).
- Miller P: Denosumab. Curr Osteoporosis Reports 2009 (in press).
- New therapies for osteoporosis: Zoledronic acid, bazedoxifene, and denosumab
Current Osteoporosis Reports
Volume 7, Issue 3 , pp 91-95
- Cover Date
- Print ISSN
- Online ISSN
- Current Science Inc.
- Additional Links
- Author Affiliations
- 1. 8641 Wilshire Boulevard, Suite 301, Beverly Hills, CA, 90211, USA