827
Views
28
CrossRef citations to date
0
Altmetric
Drug Evaluations

Update on romosozumab: a humanized monoclonal antibody to sclerostin

, & , MD

Bibliography

  • Kanis JA, Melton LJ III, Christiansen C, et al. The diagnosis of osteoporosis. J Bone Miner Res 1994;9(8):1137-41
  • NIH consensus development panel on osteoporosis prevention, diagnosis, and therapy, march 7-29, 2000: highlights of the conference. South Med J 2001;94(6):569-73
  • Burge R, Dawson-Hughes B, Solomon DH, et al. Incidence and economic burden of osteoporosis-related fractures in the united states, 2005-2025. J Bone Miner Res 2007;22(3):465-75
  • Bilezikian JP, Rubin MR, Finkelstein JS. Parathyroid hormone as an anabolic therapy for women and men. J Endocrinol Invest 2005;28(8 Suppl):41-9
  • Girotra M, Rubin MR, Bilezikian JP. The use of parathyroid hormone in the treatment of osteoporosis. Rev Endocr Metab Disord 2006;7(1-2):113-21
  • Tashjian AH Jr, Chabner BA. Commentary on clinical safety of recombinant human parathyroid hormone 1-34 in the treatment of osteoporosis in men and postmenopausal women. J Bone Miner Res 2002;17(7):1151-61
  • Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 2003;18(1):9-17
  • Costa AG, Bilezikian JP. Sclerostin: therapeutic horizons based upon its actions. Curr Osteoporos Rep 2012;10(1):64-72
  • 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
  • Li X, Zhang Y, Kang H, et al. Sclerostin binds to LRP5/6 and antagonizes canonical Wnt signaling. J Biol Chem 2005;280(20):19883-7
  • Semenov M, Tamai K, He X. SOST is a ligand for LRP5/LRP6 and a Wnt signaling inhibitor. J Biol Chem 2005;280(29):26770-5
  • 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
  • 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
  • Truswell AS. Osteopetrosis with syndactyly; a morphological variant of albers-schonberg's disease. J Bone Joint Surg Br 1958;40-B(2):209-18
  • 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
  • Brunkow ME, Gardner JC, Van Ness J, et al. Bone dysplasia sclerosteosis results from loss of the SOST gene product, a novel cystine knot-containing protein. Am J Hum Genet 2001;68(3):577-89
  • Balemans W, Ebeling M, Patel N, et al. Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST). Hum Mol Genet 2001;10(5):537-43
  • 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
  • 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
  • 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
  • Johnson ML, Kamel MA. The Wnt signaling pathway and bone metabolism. Curr Opin Rheumatol 2007;19(4):376-82
  • Johnson ML, Harnish K, Nusse R, et al. LRP5 and Wnt signaling: a union made for bone. J Bone Miner Res 2004;19(11):1749-57
  • Krishnan V, Bryant HU, Macdougald OA. Regulation of bone mass by Wnt signaling. J Clin Invest 2006;116(5):1202-9
  • Bennett CN, Longo KA, Wright WS, et al. Regulation of osteoblastogenesis and bone mass by Wnt10b. Proc Natl Acad Sci USA 2005;102(9):3324-9
  • Day TF, Guo X, Garrett-Beal L, et al. Wnt/beta-catenin signaling in mesenchymal progenitors controls osteoblast and chondrocyte differentiation during vertebrate skeletogenesis. Dev Cell 2005;8(5):739-50
  • Hill TP, Später D, Taketo MM, et al. Canonical Wnt/beta-catenin signaling prevents osteoblasts from differentiating into chondrocytes. Dev Cell 2005;8(5):727-38
  • Keller H, Kneissel M. SOST is a target gene for PTH in bone. Bone 2005;37(2):148-58
  • Silvestrini G, Ballanti P, Leopizzi M, et al. Effects of intermittent parathyroid hormone (PTH) administration on SOST mRNA and protein in rat bone. J Mol Histol 2007;38(4):261-9
  • Bellido T, Ali AA, Gubrij I, et al. Chronic elevation of parathyroid hormone in mice reduces expression of sclerostin by osteocytes: a novel mechanism for hormonal control of osteoblastogenesis. Endocrinology 2005;146(11):4577-83
  • Drake MT, Srinivasan B, Mödder UI, et al. Effects of parathyroid hormone treatment on circulating sclerostin levels in postmenopausal women. J Clin Endocrinol Metab 2010;95(11):5056-62
  • Kramer I, Keller H, Leupin O, et al. Does osteocytic SOST suppression mediate PTH bone anabolism? Trends Endocrinol Metab 2010;21(4):237-44
  • van Lierop AH, Witteveen JE, Hamdy NA, et al. Patients with primary hyperparathyroidism have lower circulating sclerostin levels than euparathyroid controls. Eur J Endocrinol 2010;163(5):833-7
  • Mirza FS, Padhi ID, Raisz LG, et al. 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
  • Gaudio A, Pennisi P, Bratengeier C, et al. Increased sclerostin serum levels associated with bone formation and resorption markers in patients with immobilization-induced bone loss. J Clin Endocrinol Metab 2010;95(5):2248-53
  • Costa AG, Cremers S, Rubin MR, et al. Circulating sclerostin in disorders of parathyroid gland function. J Clin Endocrinol Metab 2011;96(12):3804-10
  • 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):p. 27-34
  • Beighton P, Barnard A, Hamersma H, et al. The syndromic status of sclerosteosis and van Buchem disease. Clin Genet 1984;25(2):175-81
  • van Lierop AH, Hamdy NA, Hamersma H, et al. Van Buchem disease: clinical, biochemical, and densitometric features of patients and disease carriers. J Bone Miner Res 2013;28(4):848-54
  • 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
  • Beighton P. Sclerosteosis. J Med Genet 1988;25(3):200-3
  • Beighton P, Davidson J, Durr L, et al. Sclerosteosis - an autosomal recessive disorder. Clin Genet 1977;11(1):1-7
  • Hamersma H, Gardner J, Beighton P. The natural history of sclerosteosis. Clin Genet 2003;63(3):192-7
  • Bueno M, Oliván G, Jiménez A, et al. Sclerosteosis in a Spanish male: first report in a person of Mediterranean origin. J Med Genet 1994;31(12):976-7
  • Stein SA, Witkop C, Hill S, et al. Sclerosteosis: neurogenetic and pathophysiologic analysis of an American kinship. Neurology 1983;33(3):267-77
  • Tacconi P, Ferrigno P, Cocco L, et al. Sclerosteosis: report of a case in a black african man. Clin Genet 1998;53(6):497-501
  • Paes-Alves AF, Rubin JLC, Cardoso L, et al. Sclerosteosis: a marker of dutch ancestry. Rev Bras Genet 1982;4:825-34
  • Kim CA, Honjo R, Bertola D, et al. A known SOST gene mutation causes sclerosteosis in a familial and an isolated case from Brazilian origin. Genet Test 2008;12(4):475-9
  • Sugiura Y, Yasuhara T. Sclerosteosis. a case report. J Bone Joint Surg Am 1975;57(2):273-7
  • Staehling-Hampton K, Proll S, Paeper BW, et al. A 52-kb deletion in the SOST-MEOX1 intergenic region on 17q12-q21 is associated with van Buchem disease in the Dutch population. Am J Med Genet 2002;110(2):144-52
  • 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
  • Moester MJ, Papapoulos SE, Löwik CW, et al. Sclerostin: current knowledge and future perspectives. Calcif Tissue Int 2010;87(2):99-107
  • 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
  • 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
  • Li X, Ominsky MS, Niu QT, et al. Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res 2008;23(6):860-9
  • 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
  • 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
  • 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
  • Tian X, Jee WS, Li X, et al. Sclerostin antibody increases bone mass by stimulating bone formation and inhibiting bone resorption in a hindlimb-immobilization rat model. Bone 2011;48(2):197-201
  • 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. Endocrinology 2011;152(9):3312-22
  • Eddleston A, Marenzana M, Moore AR, et al. A short treatment with an antibody to sclerostin can inhibit bone loss in an ongoing model of colitis. J Bone Miner Res 2009;24(10):1662-71
  • Spatz JM, Ellman R, Cloutier AM, et al. Sclerostin antibody inhibits skeletal deterioration due to reduced mechanical loading. J Bone Miner Res 2013;28(4):865-74
  • 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
  • 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
  • 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
  • Cui L, Cheng H, Song C, et al. Time-dependent effects of sclerostin antibody on a mouse fracture healing model. J Musculoskelet Neuronal Interact 2013;13(2):178-84
  • 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
  • Lewiecki EM. Sclerostin monoclonal antibody therapy with AMG 785: a potential treatment for osteoporosis. Expert Opin Biol Ther 2011;11(1):117-27
  • 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]
  • Graeff C, Campbell G, Pena J, et al. Effects of romosozumab administration on trabecular and cortical bone assessed with quantitative computed tomography and finite element analysis. ECTS abstracts 2013. [Epub ahead of print]
  • 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
  • Genant HK, Boonen S, Bolognese MA, et al. Effect of romosozumab on lumbar spine and hip volumetric bone mineral density (vBMD) as assessed by quantitative computed tomography (QCT). J Bone Miner Res 2013;28 (Suppl 1). Available from: http://www.asbmr.org/asbmr-2013-abstract-detail?aid=67672d13-3ff4-4d27-81cc-eb47f22ecf45 [Accesed 2 November 2013]
  • Available from: http://www.clinicaltrials.gov/ct2/show/NCT01833754?term=Romosozumab&rank=1 [Acessed on 20 November 2013]
  • Available from: http://www.clinicaltrials.gov/ct2/show/NCT01631214?term=Romosozumab&rank=5 [Acessed on 20 November 2013]
  • McColm J, Hu L, Womack T, et al. Single- and multiple-dose randomized studies of blosozumab, a monoclonal antibody against sclerostin, in healthy postmenopausal women. J Bone Miner Res 2013. [Epub ahead of print]
  • Watts NB, Bilezikian JP. Commentary: advances in target-specific therapy for osteoporosis. J Clin Endocrinol Metab 2014. [Epub ahead of print]
  • Chen P, Satterwhite JH, Licata AA, et al. Early changes in biochemical markers of bone formation predict BMD response to teriparatide in postmenopausal women with osteoporosis. J Bone Miner Res 2005;20(6):962-70
  • Ominsky M, Libanati C, Boyce RW, et al. Continuous modeling-based bone formation: a novel mechanism that could explain the sustained increases in hip bone mineral density (BMD) with denosumab treatment. J Bone Miner Res 2013;28 (Suppl 1). Available from: http://www.asbmr.org/asbmr-2013-abstract-detail?aid=89fd1f4a-ff73-4a62-accc-d9ae7dac6e22 [Accessed 1 December 2013]
  • Ross RD, Edwards LH, Acerbo AS, et al. Bone matrix quality following sclerostin antibody treatment. J Bone Miner Res 2014. [Epub ahead of print]
  • Kansara M, Tsang M, Kodjabachian L, et al. Wnt inhibitory factor 1 is epigenetically silenced in human osteosarcoma, and targeted disruption accelerates osteosarcomagenesis in mice. J Clin Invest 2009;119(4):837-51

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.