Romosozumab/CDP7851 for the treatment of osteoporosis

References

• Kanis JA. Assessment of osteoporosis at the primary health-care level. University of Sheffield: World Health Organization; 2007. Available from: www.who.int/chp/topics/rheumatic/en/index.html
   Google Scholar
• Kanis JA. Diagnosis of osteoporosis. Osteoporos Int 1997;7(Suppl 3):S108-16
   PubMed Web of Science ®Google Scholar
• Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17(12):1726-33
   PubMed Web of Science ®Google Scholar
• Kanis JA. Diagnosis of osteoporosis and assessment of fracture risk. Lancet 2002;359(9321):1929-36
   PubMed Web of Science ®Google Scholar
• Cooper C, Atkinson EJ, Jacobsen SJ, et al. Population-based study of survival after osteoporotic fractures. Am J Epidemiol 1993;137(9):1001-5
   PubMed Web of Science ®Google Scholar
• Keene GS, Parker MJ, Pryor GA. Mortality and morbidity after hip fractures. BMJ 1993;307(6914):1248-50
   PubMed Web of Science ®Google Scholar
• Hernlund E, Svedbom A, Ivergard M, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Archives of osteoporosis 2013;8(1-2):136
   PubMed Web of Science ®Google Scholar
• Katznelson L, Finkelstein JS, Schoenfeld DA, et al. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab 1996;81(12):4358-65
   PubMed Web of Science ®Google Scholar
• van der Werff ten Bosch JJ, Bot A. Some skeletal dimensions of males with isolated gonadotrophin deficiency. Neth J Med 1992;41(5-6):259-63
   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(18):1809-22
   PubMed Web of Science ®Google Scholar
• Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009;361(8):756-65
   PubMed Web of Science ®Google Scholar
• Khosla S, Burr D, Cauley J, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007;22(10):1479-91
   PubMed Web of Science ®Google Scholar
• Shane E, Burr D, Ebeling PR, et al. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2010;25(11):2267-94
   PubMed Web of Science ®Google Scholar
• Recker RR, Marin F, Ish-Shalom S, et al. Comparative effects of teriparatide and strontium ranelate on bone biopsies and biochemical markers of bone turnover in postmenopausal women with osteoporosis. J Bone Miner Res 2009;24(8):1358-68
   PubMed Web of Science ®Google Scholar
• Meunier PJ, Roux C, Ortolani S, et al. Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis. Osteoporos Int 2009;20(10):1663-73
   PubMed Web of Science ®Google Scholar
• Greenspan SL, Bone HG, Ettinger MP, et al. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med 2007;146(5):326-39
   PubMed Web of Science ®Google Scholar
• Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001;344(19):1434-41
   PubMed Web of Science ®Google Scholar
• Saag KG, Shane E, Boonen S, et al. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med 2007;357(20):2028-39
   PubMed Web of Science ®Google Scholar
• Rubin MR, Bilezikian JP. The anabolic effects of parathyroid hormone therapy. Clin Geriatr Med 2003;19(2):415-32
   PubMed Web of Science ®Google Scholar
• Andrews EB, Gilsenan AW, Midkiff K, et al. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years. J Bone Miner Res 2012;27(12):2429-37
   PubMed Web of Science ®Google Scholar
• Veverka V, Henry AJ, Slocombe PM, et al. Characterization of the structural features and interactions of sclerostin: molecular insight into a key regulator of Wnt-mediated bone formation. J Biol Chem 2009;284(16):10890-900
   PubMed Web of Science ®Google Scholar
• Balemans W, Van Hul W. Extracellular regulation of BMP signaling in vertebrates: a cocktail of modulators. Dev Biol 2002;250(2):231-50
   PubMed Web of Science ®Google Scholar
• Kusu N, Laurikkala J, Imanishi M, et al. Sclerostin is a novel secreted osteoclast-derived bone morphogenetic protein antagonist with unique ligand specificity. J Biol Chem 2003;278(26):24113-17
   PubMed Web of Science ®Google Scholar
• van Bezooijen RL, Roelen BA, Visser A, et al. Sclerostin is an osteocyte-expressed negative regulator of bone formation, but not a classical BMP antagonist. J Exp Med 2004;199(6):805-14
   PubMed Web of Science ®Google Scholar
• Winkler DG, Sutherland MK, Geoghegan JC, et al. Osteocyte control of bone formation via sclerostin, a novel BMP antagonist. EMBO J 2003;22(23):6267-76
   PubMed Web of Science ®Google Scholar
• Poole KE, van Bezooijen RL, Loveridge N, et al. Sclerostin is a delayed secreted product of osteocytes that inhibits bone formation. FASEB J 2005;19(13):1842-4
   PubMed Web of Science ®Google Scholar
• van Bezooijen RL, Svensson JP, Eefting D, et al. Wnt but not BMP signaling is involved in the inhibitory action of sclerostin on BMP-stimulated bone formation. J Bone Miner Res 2007;22(1):19-28
   PubMed Web of Science ®Google Scholar
• Krause C, Korchynskyi O, de Rooij K, et al. Distinct modes of inhibition by sclerostin on bone morphogenetic protein and Wnt signaling pathways. J Biol Chem 2010;285(53):41614-26
   PubMed Web of Science ®Google Scholar
• Johnson ML, Kamel MA. The Wnt signaling pathway and bone metabolism. Curr Opin Rheumatol 2007;19(4):376-82
   PubMed Web of Science ®Google Scholar
• Liu C, Li Y, Semenov M, et al. Control of beta-catenin phosphorylation/degradation by a dual-kinase mechanism. Cell 2002;108(6):837-47
   PubMed Web of Science ®Google Scholar
• Sclerostin regulates RANKL expression in osteocytes. BoneKEy reports 2012;1:19
   Google Scholar
• Wijenayaka AR, Kogawa M, Lim HP, et al. Sclerostin stimulates osteocyte support of osteoclast activity by a RANKL-dependent pathway. PLoS One 2011;6(10):e25900
   PubMed Web of Science ®Google Scholar
• Lin C, Jiang X, Dai Z, et al. Sclerostin mediates bone response to mechanical unloading through antagonizing Wnt/beta-catenin signaling. J Bone Miner Res 2009;24(10):1651-61
   PubMed Web of Science ®Google Scholar
• Sutherland MK, Geoghegan JC, Yu C, et al. Unique regulation of SOST, the sclerosteosis gene, by BMPs and steroid hormones in human osteoblasts. Bone 2004;35(2):448-54
   PubMed Web of Science ®Google Scholar
• Keller H, Kneissel M. SOST is a target gene for PTH in bone. Bone 2005;37(2):148-58
   PubMed Web of Science ®Google Scholar
• Drake MT, Srinivasan B, Modder UI, et al. Effects of parathyroid hormone treatment on circulating sclerostin levels in postmenopausal women. J Clin Endocrinol Metab 2010;95(11):5056-62
   PubMed Web of Science ®Google Scholar
• Mirza FS, Padhi ID, Raisz LG, Lorenzo JA. Serum sclerostin levels negatively correlate with parathyroid hormone levels and free estrogen index in postmenopausal women. J Clin Endocrinol Metab 2010;95(4):1991-7
   PubMed Web of Science ®Google Scholar
• Modder UI, Clowes JA, Hoey K, et al. Regulation of circulating sclerostin levels by sex steroids in women and in men. J Bone Miner Res 2011;26(1):27-34
   PubMed Web of Science ®Google Scholar
• Paccou J, Mentaverri R, Renard C, et al. The relationships between serum sclerostin, bone mineral density, and vascular calcification in rheumatoid arthritis. J Clin Endocrinol Metab 2014;99(12):4740-8
   PubMed Web of Science ®Google Scholar
• Ishimura E, Okuno S, Ichii M, et al. Relationship between serum sclerostin, bone metabolism markers, and bone mineral density in maintenance hemodialysis patients. J Clin Endocrinol Metab 2014;99(11):4315-20
   PubMed Web of Science ®Google Scholar
• Register TC, Hruska KA, Divers J, et al. Sclerostin is positively associated with bone mineral density in men and women and negatively associated with carotid calcified atherosclerotic plaque in men from the African American-Diabetes Heart Study. J Clin Endocrinol Metab 2014;99(1):315-21
   PubMed Web of Science ®Google Scholar
• Arasu A, Cawthon PM, Lui LY, et al. Serum sclerostin and risk of hip fracture in older Caucasian women. J Clin Endocrinol Metab 2012;97(6):2027-32
   PubMed Web of Science ®Google Scholar
• Ardawi MS, Rouzi AA, Al-Sibiani SA, et al. High serum sclerostin predicts the occurrence of osteoporotic fractures in postmenopausal women: the Center of Excellence for Osteoporosis Research Study. J Bone Miner Res 2012;27(12):2592-602
   PubMed Web of Science ®Google Scholar
• Garnero P, Sornay-Rendu E, Munoz F, et al. Association of serum sclerostin with bone mineral density, bone turnover, steroid and parathyroid hormones, and fracture risk in postmenopausal women: the OFELY study. Osteoporos Int 2013;24(2):489-94
   PubMed Web of Science ®Google Scholar
• Clarke BL, Drake MT. Clinical utility of serum sclerostin measurements. BoneKEy reports 2013;2:361
   PubMedGoogle Scholar
• Van Buchem FS, Hadders HN, Ubbens R. An uncommon familial systemic disease of the skeleton: hyperostosis corticalis generalisata familiaris. Acta Radiol 1955;44(2):109-20
   PubMed Web of Science ®Google Scholar
• Truswell AS. Osteopetrosis with syndactyly; a morphological variant of Albers-Schonberg’s disease. J Bone Joint Surg Br 1958;40-B(2):209-18
   PubMedGoogle Scholar
• Balemans W, Ebeling M, Patel N, et al. Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST). Human Mol Genet 2001;10(5):537-43
   PubMed Web of Science ®Google Scholar
• Balemans W, Cleiren E, Siebers U, et al. A generalized skeletal hyperostosis in two siblings caused by a novel mutation in the SOST gene. Bone 2005;36(6):943-7
   PubMed Web of Science ®Google Scholar
• Balemans W, Patel N, Ebeling M, et al. Identification of a 52 kb deletion downstream of the SOST gene in patients with van Buchem disease. J Med Genet 2002;39(2):91-7
   PubMed Web of Science ®Google Scholar
• Beighton P, Barnard A, Hamersma H, van der Wouden A. The syndromic status of sclerosteosis and van Buchem disease. Clini Genet 1984;25(2):175-81
   PubMed Web of Science ®Google Scholar
• Gardner JC, van Bezooijen RL, Mervis B, et al. Bone mineral density in sclerosteosis; affected individuals and gene carriers. J Clin Endocrinol Metab 2005;90(12):6392-5
   PubMed Web of Science ®Google Scholar
• Stein SA, Witkop C, Hill S, et al. Sclerosteosis: neurogenetic and pathophysiologic analysis of an American kinship. Neurology 1983;33(3):267-77
   PubMed Web of Science ®Google Scholar
• Wergedal JE, Veskovic K, Hellan M, et al. Patients with Van Buchem disease, an osteosclerotic genetic disease, have elevated bone formation markers, higher bone density, and greater derived polar moment of inertia than normal. J Clin Endocrinol Metab 2003;88(12):5778-83
   PubMed Web of Science ®Google Scholar
• van Lierop AH, Hamdy NA, Hamersma H, et al. Patients with sclerosteosis and disease carriers: human models of the effect of sclerostin on bone turnover. J Bone Miner Res 2011;26(12):2804-11
   PubMed Web of Science ®Google Scholar
• Li X, Ominsky MS, Warmington KS, et al. Sclerostin antibody treatment increases bone formation, bone mass, and bone strength in a rat model of postmenopausal osteoporosis. J Bone Miner Res 2009;24(4):578-88
   PubMed Web of Science ®Google Scholar
• Li X, Warmington KS, Niu QT, et al. Inhibition of sclerostin by monoclonal antibody increases bone formation, bone mass, and bone strength in aged male rats. J Bone Miner Res 2010;25(12):2647-56
   PubMed Web of Science ®Google Scholar
• Ominsky MS, Vlasseros F, Jolette J, et al. Two doses of sclerostin antibody in cynomolgus monkeys increases bone formation, bone mineral density, and bone strength. J Bone Miner Res 2010;25(5):948-59
   PubMed Web of Science ®Google Scholar
• Marenzana M, Greenslade K, Eddleston A, et al. Sclerostin antibody treatment enhances bone strength but does not prevent growth retardation in young mice treated with dexamethasone. Arthritis Rheum 2011;63(8):2385-95
   PubMed Web of Science ®Google Scholar
• Hamann C, Rauner M, Hohna Y, et al. Sclerostin antibody treatment improves bone mass, bone strength, and bone defect regeneration in rats with type 2 diabetes mellitus. J Bone Miner Res 2013;28(3):627-38
   PubMed Web of Science ®Google Scholar
• Ominsky MS, Li C, Li X, et al. Inhibition of sclerostin by monoclonal antibody enhances bone healing and improves bone density and strength of nonfractured bones. J Bone Miner Res 2011;26(5):1012-21
   PubMed Web of Science ®Google Scholar
• Agholme F, Li X, Isaksson H, et al. Sclerostin antibody treatment enhances metaphyseal bone healing in rats. J Bone Miner Res 2010;25(11):2412-18
   PubMed Web of Science ®Google Scholar
• Li X, Ominsky MS, Warmington KS, et al. Increased bone formation and bone mass induced by sclerostin antibody is not affected by pretreatment or cotreatment with alendronate in osteopenic, ovariectomized rats. Endocrinol 2011;152(9):3312-22
   PubMed Web of Science ®Google Scholar
• Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab 2010;95(4):1838-45
   PubMed Web of Science ®Google Scholar
• Padhi D, Jang G, Stouch B, et al. Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res 2011;26(1):19-26
   PubMed Web of Science ®Google Scholar
• Padhi D, Allison M, Kivitz AJ, et al. Multiple doses of sclerostin antibody romosozumab in healthy men and postmenopausal women with low bone mass: A randomized, double-blind, placebo-controlled study. J Clin Pharmacol 2013. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med 2014;370(5):412-20
   PubMed Web of Science ®Google Scholar
• McClung MR, Chines A, Brown J, et al. Effects of 2 Years of Treatment With Romosozumab Followed by 1 Year of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density. J Bone Miner Res 2014;29 (Supp 1). Available from: www.asbmr.org/education/AbstractDetail?aid=9114bfe4-a51e-4e38-8a67-5d0deef408c6 [Last accessed 4 November 2014]
   Google Scholar
• ClinicalTrials.gov [Internet]. Last updated May 9 CgIN. Phase 2 Study of AMG 785 in Postmenopausal Women With Low Bone Mineral Density. Available from: http://clinicaltrialsgov
   Google Scholar
• Whitmarsh T, Treece G, Gee A, et al. Romosozumab and teriparatide effects on vertebral cortical mass, thickness and density in postmenopausal women with low bone mineral density (BMD). J Bone Miner Res 2014;29(Supp 1). Available from: www.asbmr.org/education/AbstractDetail?aid=9114bfe4-a51e-4e38-8a67-5d0deef408c6. [Last accessed 23 February 2015]
   Google Scholar
• Damm T, Libanati C, Pena J, et al. Romosozumab significantly improves vertebral cortical bone mass and structure compared with teriparatide: HR-QCT analyses of randomized controlled trial results in postmenopausal women with low BMD. J Bone Miner Res 2014;29(Supp 1). Available from: www.asbmr.org/education/AbstractDetail?aid=9114bfe4-a51e-4e38-8a67-5d0deef408c6. [Last accessed 23 February 2015]
   Google Scholar
• Registrational Study With AMG 785 to treat postmenopausal osteoporosis (FRAME). Available from: https://clinicaltrials.gov/ct2/show/NCT01575834
   Google Scholar
• Study to determine the efficacy and safety of romosozumab in the treatment of postmenopausal women with osteoporosis. Available from: https://clinicaltrials.gov/ct2/show/NCT01631214
   Google Scholar
• An open-label study to evaluate the effect of treatment with AMG 785 or teriparatide in postmenopausal women (STRUCTURE). Available from: https://clinicaltrials.gov/ct2/show/NCT01796301
   Google Scholar
• Zhu D, Mackenzie NC, Millan JL, et al. The appearance and modulation of osteocyte marker expression during calcification of vascular smooth muscle cells. PLoS One 2011;6(5):e19595
   PubMed Web of Science ®Google Scholar
• Brandenburg VM, Kramann R, Koos R, et al. Relationship between sclerostin and cardiovascular calcification in hemodialysis patients: a cross-sectional study. BMC Nephrol 2013;14:219
   PubMed Web of Science ®Google Scholar
• Tsai JN, Uihlein AV, Lee H, et al. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet 2013;382(9886):50-6
   PubMed Web of Science ®Google Scholar