Biological agents in management of osteoporosis

European Journal of Clinical Pharmacology

Volumn 70, Issue 11, 2014, Pages 1291-1301

  Tella, Sri Harsha ^a   Gallagher, J Christopher ^a  

^a CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Bone mineral density; Cathepsin K; Osteoporosis

Indexed keywords

ALENDRONIC ACID; ANABOLIC AGENT; BIOLOGICAL MARKER; BIOLOGICAL PRODUCT; BISPHOSPHONIC ACID DERIVATIVE; BLOSOZUMAB; BONE DENSITY CONSERVATION AGENT; CATHEPSIN K INHIBITOR; DENOSUMAB; ESTROGEN; ODANACATIB; PARATHYROID HORMONE[1-34]; PLACEBO; RALOXIFENE; ROMOSOZUMAB; SCLEROSTIN; BIOLOGICAL FACTOR; BONE MORPHOGENETIC PROTEIN; CATHEPSIN K; GENETIC MARKER; MONOCLONAL ANTIBODY; SOST PROTEIN, HUMAN;

BIOLOGICAL THERAPY; BONE MASS; BONE MINERALIZATION; BONE STRUCTURE; BONE TURNOVER; DRUG EFFICACY; DRUG TOLERABILITY; HORMONAL THERAPY; HUMAN; INTERVENTION STUDY; MONOTHERAPY; NONHUMAN; OSSIFICATION; OSTEOLYSIS; OSTEOPOROSIS; REVIEW; ANIMAL; ANTAGONISTS AND INHIBITORS; GENETIC MARKER;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; BIOLOGICAL FACTORS; BONE DENSITY CONSERVATION AGENTS; BONE MORPHOGENETIC PROTEINS; CATHEPSIN K; GENETIC MARKERS; HUMANS; OSTEOPOROSIS; TERIPARATIDE;

EID: 84919704863     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-014-1735-5     Document Type: Review

References (60)

1. Pacifici R (1996) Estrogen, cytokines, and pathogenesis of postmenopausal osteoporosis. J Bone Miner Res 11:1043-1051
2. Riggs BL, Khosla S, Melton LJ III (1998) A unitary model for involutional osteoporosis: estrogen deficiency causes both type I and type II osteoporosis in postmenopausal women and contributes to bone loss in aging men. J Bone Miner Res 13:763-773
3. Hofbauer LC et al (2000) The roles of osteoprotegerin and osteoprotegerin ligand in the paracrine regulation of bone resorption. J Bone Miner Res 15:2-12
4. Shevde NK, Bendixen AC, Dienger KM, Pike JW (2000) Estrogens suppress RANK ligand-induced osteoclast differentiation via a stromal cell independent mechanism involving c-Jun repression. Proc Natl Acad Sci U S A 97:7829-7834
5. Balemans W, Ebeling M, Patel N et al (2001) Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST). Hum Mol Genet 10:537-543
6. Loots GG, Kneissel M, Keller H et al (2005) Genomic deletion of a long-range bone enhancer misregulates sclerostin in Van Buchem disease. Genome Res 15:928-935
7. Li X, Ominsky MS, Niu QT et al (2008) Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res 23:860-869
8. Li X, Ominsky MS, Warmington KS et al (2009) Sclerostin antibody treatment increases bone formation, bone mass, and bone strength in a rat model of postmenopausal osteoporosis. J Bone Miner Res 24:578-588
9. Baron R, Kneissel M (2013) WNT signaling in bone homeostasis and disease: from human mutations to treatments. Nat Med 19:179-192
10. Moester MJ, Papapoulos SE, Lowik CW et al (2010) Sclerostin: current knowledge and future perspectives. Calcif Tissue Int 87:99-107
11. Ke HZ, Richards WG, Li X, Ominsky MS (2012) Sclerostin and Dickkopf-1 as therapeutic targets in bone diseases. Endocr Rev 33(5):747-783. doi: 10.1210/er.2011-1060. Epub 2012 Jun 20
12. Glantschnig H, Hampton RA, Lu P et al (2010) Generation and selection of novel fully human monoclonal antibodies that neutralize Dickkopf-1 (DKK1) inhibitory function in vitro and increase bone mass in vivo. J Biol Chem 285(51):40135-40147. doi: 10.1074/jbc.M110.166892
13. Prolia 60 mg solution for injection in a pre-filled syringe: EU summary of product characteristics. Breda: Amgen Europe B.V., 2010 May 26.
14. Xgeva (denosumab) injection, for subcutaneous use: US prescribing information. Thousand Oaks (CA): Amgen Inc., 2010.
15. Miller PD, Bolognese MA, Lewiecki EM et al (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(2):222-229
16. McClung MR, Lewiecki EM, Cohen SB et al (2006) Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 354(8):821-831
17. Lewiecki EM, Miller PD, McClung MR et al (2007) Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res 22(12):1832-1841
18. Cummings SR, San Martin J, McClung MR et al (2009) Denosumab for preventionof fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756
19. H.G. Bone, R. Chapurlat, M.L. Brandi, et al., The effect of thee or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the freedom extension, J. Clin. Endocrinol. Metab. (2013) (Epub ahead of print).
20. Brown JP, Prince RL, Deal C et al (2009) Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res 24(1):153-161
21. Kendler DL, Roux C, Benhamou CL et al (2010) Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res 25(1):72-81
22. Reid IR, Miller PD, Brown JP et al (2010) Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res 25(10):2256-2265
23. Seeman E, Delmas PD, Hanley DA et al (2010) Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res 25(8):1886-1894
24. Bekker PJ, Holloway DL, Rasmussen AS et al (2004) A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res 19(7):1059-1066
25. Eastell R, Christiansen C, Grauer A, et al. Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J Bone Miner Res. Epub 2010 Sep 13
26. Block GA, Bone HG, Fang L et al (2012) A single-dose study of denosumab in patients with various degrees of renal impairment. J Bone Miner Res 27(7):1471-1479. doi: 10.1002/jbmr.1613
27. Neer RM, Arnaud CD, Zanchetta JR et al (2001) Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434
28. Zanchetta JR, Bogado CE, Ferretti JL et al (2003) Effects of teriparatide [recombinant human parathyroid hormone (1-34)] on cortical bone in postmenopausal women with osteoporosis. J Bone Miner Res 18:539-543
29. Greenspan SL, Bone HG, Ettinger MP et al (2007) 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 146:326
30. Eastell R, Nickelsen T, Marin F et al (2009) Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomized, controlled European study of Forsteo (EUROFORS). J Bone Miner Res 24:726
31. Lindsay R, Nieves J, Formica C et al (1997) Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis. Lancet 350:550-555
32. Cosman F, Nieves J, Woelfert L et al (2001) Parathyroid hormone added to established hormone therapy: effects on vertebral fracture and maintenance of bone mass after parathyroid hormone withdrawal. J Bone Miner Res 16:925-931
33. Ste-Marie LG, Schwartz SL, Hossain A, Desaiah D, Gaich GA (2006) Effect of teriparatide [rhPTH (1-34)] on BMD when given to postmenopausal women receiving hormone replacement therapy. J Bone Miner Res 21:283-291
34. Deal C, Omizo M, Schwartz EN et al (2005) Combination teriparatide and raloxifene therapy for postmenopausal osteoporosis: results from a 6-month double-blind placebo-controlled trial. J Bone Miner Res 20:1905-1911
35. Black DM, Greenspan SL, Ensrud KE et al (2003) The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med 349:1207-1215
36. Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM (2003) The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med 349:1216-1226
37. Black DM, Bilezikian JP, Ensrud KE et al (2005) One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med 353:555-565
38. J.N. Tsai, A.V. Uihlein, H. Lee, Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial, Lancet 382 (July (9886)) (2013) 50-56, http://dx.doi.org/ 10.1016/S0140-6736(13)60856-9.
39. Leder BZ, Tsai JN, Uihlein AV Two years of denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014 Feb 11:jc20134440. [Epub ahead of print]
40. Kurland ES, Cosman F, McMahon DJ et al (2000) Parathyroid hormone as a therapy for idiopathic osteoporosis in men: effects on bone mineral density and bone markers. J Clin Endocrinol Metab 85:3069-3076
41. Orwoll ES, Scheele WH, Paul S et al (2003) The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 18:9-17
42. Forteo (teriparatide [rDNA origin] injection) [package insert]. Product information. Indianapolis, Ind: Eli Lilly and Co; 2002.
43. Babcook J, Leslie K, Olsen O et al (1996) A novel strategy for generating monoclonal antibodies from single, isolated lymphocytes producing antibodies of defined specificities. Proc Natl Acad Sci U S A 93(15):7843-7848
44. Veverka V, Henry A, Slocombe P et al (2009) Characterization of the structural features and interactions of sclerostin: molecular insight into a key regulator of Wnt-mediated bone formation. J Biol Chem 284:10890-10900
45. Ominsky M, Vlasseros F, Jolette J et al (2010) Two doses of sclerostin antibody in cynomolgus monkeys increases bone formation, bone mineral density, and bone strength. J Bone Miner Res 25:948-959
46. Agholme F, Li X, Isaksson H et al (2010) Sclerostin antibody treatment enhances metaphyseal bone healing in rats. J Bone Miner Res 25(11):2412-2418
47. Li X, Warmington KS, Niu QT, Asuncion FJ, Barrero M, Grisanti M et al (2010) Inhibition of sclerostin by monoclonal antibody increases bone formation, bone mass and bone strength in aged male rats. J Bone Miner Res 25(12):2647-2656
48. Ominsky M, Samadfan R, Jolette J et al (2009) Sclerostin monoclonal antibody stimulates bone formation and improves the strength and density of the fracture callus and lumbar spine in a primate fibular osteotomy model. J Bone Miner Res 24(1):S89-S90
49. Padhi D, Jang G, Stouch B, Fang L, Posvar E (2011) Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res 26:19-26
50. McClung M, Grauer A, Boonen S et al (2012) Inhibition of sclerostin with AMG 785 in postmenopausal women with low bone mineral density: phase 2 trial results. J Bone Miner Res 27(1):S8
51. McClung MR, Grauer A, Boonen S et al (2014) Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med 370(5):412-420. doi: 10.1056/NEJMoa1305224. Epub 2014 Jan 1
52. McColm J, Womack T, Hu L et al (2012) Blosozumab, a humanized monoclonal antibody against sclerostin, demonstrated anabolic effects on bone in postmenopausal women. J Bone Miner Res 27(1):S9
53. Benson, C., Robins, D., Recker, R., et al. (2013) Effect of blosozumab on bone mineral density: results of a phase 2 study of postmenopausal women with low bone mineral density. Bone Abstracts 1: OC5.3.
54. Rodan SB, Duong LT (2008) Cathepsin K - a new molecular target for osteoporosis. IBMS BoneKEy 5:16-24
55. Stoch SA, Zajic S, Stone J et al (2009) Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther 86:175-182
56. Bone HG, McClung MR, Roux C (2010) Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density. J Bone Miner Res 25:937-947
57. Brixen K, Chapurlat R, Cheung AM et al (2013) Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial. J Clin Endocrinol Metab 98:571-580
58. Eisman JA, Bone HG, Hosking DJ et al (2011) Odanacatib in the treatment of postmenopausal women with low bone mineral density: three-year continued therapy and resolution of effect. J Bone Miner Res 26:242-251
59. Tella SH, Gallagher JC (2013) Bazedoxifene + conjugated estrogens in HT for the prevention of osteoporosis and treatment of vasomotor symptoms associated with the menopause. Expert Opin Pharmacother 14(17):2407-2420. doi: 10.1517/14656566.2013.844790. Epub 2013 Oct 7
60. Tella SH, Gallagher JC (2013) Prevention and treatment of postmenopausal osteoporosis. J Steroid Biochem Mol Biol. doi: 10.1016/j.jsbmb.2013.09.008