Denosumab for the treatment of osteoporosis

Expert Opinion on Drug Metabolism and Toxicology

Volumn 11, Issue 3, 2015, Pages 461-470

  Zaheer, Sarah ^a   LeBoff, Meryl ^a   Lewiecki, E Michael ^b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b NEW MEXICO CLINICAL RESEARCH AND OSTEOPOROSIS CENTER   (United States)

Author keywords

Denosumab; mAb; Osteoporosis; Receptor activator of nuclear factor kappa B ligand; Treatment

Indexed keywords

AMINO TERMINAL TELOPEPTIDE; DENOSUMAB; OSTEOCLAST DIFFERENTIATION FACTOR; MONOCLONAL ANTIBODY;

BONE DENSITY; BONE TURNOVER; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG METABOLISM; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; FRAGILITY FRACTURE; HUMAN; OSSIFICATION; OSTEOPOROSIS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; RISK REDUCTION; CLINICAL TRIAL (TOPIC); COMPLICATION; DRUG EFFECTS; OSTEOPOROTIC FRACTURES; TIME FACTOR;

ANTIBODIES, MONOCLONAL, HUMANIZED; BONE DENSITY; CLINICAL TRIALS AS TOPIC; DENOSUMAB; HUMANS; OSTEOPOROSIS; OSTEOPOROTIC FRACTURES; TIME FACTORS;

EID: 84923062171     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2015.1000860     Document Type: Review

References (55)

1. Wright N, Looker A, Saag K, et al. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine. J Bone Miner Res 2014;29(10):2520-6
2. Burge R, Dawson-Hughes B, Solomon D, 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
3. Hannan E, Magaziner J, Wang J, et al. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA 2001;285:2736-42
4. Cooper C, Atkinson EJ, Jacobsen SJ. Population-based study of survival after osteoporotic fractures. Am J Epidemiol 1993;137:1001-5
5. Roux C, Wyman A, Hooven F, et al. Burden of non-hip, non-vertebral fractures on quality of life in postmenopausal women. Osteoporos Int 2012;23(12):2863-71
6. Dawson-Hughes B, Looker A, Tosteson A, et al. The potential impact of new National Osteoporosis Foundation guidance on treatment patterns. Osteoporos Int 2010;21(1):41-52
7. US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. US Department of Health and Human Services, Office of the Surgeon General; 2004
8. Kothawala P, Badamgarav E, Ryu S, et al. Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis. Mayo Clin Proc 2007;82(12):1493-501
9. Food and Drug Administration. Background document for meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee 2011
10. Liberman U, Weiss S, Broll J, et al. Effects of oral alendronate on bone mineral denisty and the incidence of fracture in postmenopausal osteoporosis. N Engl J Med 1995;333(22):1437-43
11. Mcclung M, Geusens P, Miller P, et al. Effects of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 2001;344(5):333-40
12. Chestnut CI, 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(8):1241-9
13. Black D, Delmas P, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356(18):1809-22
14. Chestnut CI, Silverman S, Andriano K, et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. Am J Med 2000;109(4):267-76
15. Rossouw J, Anderson G, Prentice R, et al. Risks and benefits of estrogen plus protestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA 2002;288(3):321-33
16. Anderson G, Limacher M, Assaf A, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291(14):1701-12
17. Ettinger B, Black D, Mitlak B, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 1999;282(7):637-45
18. Lindsay R, Gallagher J, 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(3):1045-52
19. Neer R, Arnaud C, Zanchetta J, 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
20. Cummings S, San Martin J, Mcclung M, et al. Denosumab for prevention of fractures in postmenpausal women with osteoporosis. N Engl J Med 2009;361(8):756-65
21. O'Donnell S, Cranney A, Wells G, et al. Strontium ranelate for preventing and treating postmenopausal osteoporosis. Cochrane Database Syst Rev 2006;19(3):CD005326
22. Greenspan S, Bone H, Ettinger M, 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
23. Bone H, McClung M, Roux C, et al. Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density. J Bone Miner Res 2010;25(5):937-47
24. Padhi D, Jang G, Stouch B, et al. Singledose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res 2011;26(1):19-26
25. Recker R, Benson C, Matsumoto T, et al. A randomized, double-blind phase 2 clinical trial of blosozumab, a sclerostin antibody, in postmenopausal women with low bone mineral density. J Bone Miner Res 2014. [Epub ahead of print]
26. Amgen, Inc. Prolia (denosumab) prescribing information. 2010; updated 2014
27. Bekker P, Holloway D, Rasmussen A, et al. A single-dose placebo-controlled study of AMG 162, a fully monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res 2004;19(7):1059-66
28. Sutjandra L, Rodriguez R, Doshi S, et al. Population pharmacokinetic metaanalysis of denosumab in healthy subjects and postmenopausal women with osteopenia or osteoporosis. Clin Pharmacokinet 2011;50(12):793-807
29. Block G, Bone H, Fang L, et al. A single-dose study of denosumab in patients with various degrees of renal impairment. J Bone Miner Res 2012;27(7):1471-9
30. Miller P, Bolognese M, Lewiecki E, et al. 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 2008;43(2):222-9
31. Papapoulos S, Lippuner K, Roux C, et al. Eight years of denosumab treatment in postmenopausal women with osteoporosis: results from the first five years of the FREEDOM extension. ASBMR 2013 Annual Meeting; 2013. Oral Poster Session; Presentation Number: LB-MO26
32. Brown J, Roux C, Torring O, et al. Discontinuation of denosumab and associated fracture incidence: analysis from the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial. J Bone Miner Res 2013;28(4):746-52
33. Brown J, Reid I, Wagman R, et al. Effects of up to 5 Years of Denosumab Treatment on Bone Histology and Histomorphometry: the FREEDOM Study Extension. J Bone Miner Res 2014;29(9):2051-6
34. Brown J, Prince R, Deal C, et al. 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 2009;24(1):153-61
35. Kendler D, Roux C, Benhamou C, et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res 2009;25(1):72-81
36. Roux C, Hofbauer L, Ho P, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone 2014;58:48-54
37. Recknor C, Czerwinski E, Bone H, et al. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol 2013;121(6):1291-9
38. Orwoll E, Teglbjærg C, Langdahl B, et al. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab 2012;97(9):3161-9
39. Smith M, Egerdie B, Toriz N, et al. Denosumab in men receiving androgendeprivation therapy for prostate cancer. N Engl J Med 2009;361(8):745-55
40. Ellis GK, Bone HG, Chlebowski R, et al. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol 2008;26:4875-82
41. Tsai J, Uihlein A, 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
42. Cosman F, Eriksen E, Recknor C, et al. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH (1-34)] in postmenopausal osteoporosis. J Bone Miner Res 2011;26(3):503-11
43. Finkelstein J, Wyland J, Lee H, et al. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab 2010;95(4):1838-45
44. Freemantle N, Satram-Hoang A, Tang E, et al. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int 2012;23(1):317-26
45. Yassin M, Soliman A, De Sanctis V, et al. Effects of the anti-receptor activator of nuclear factor kappa B ligand denusomab on beta thalassemia majorinduced osteoporosis. Indian J Endocrinol Metab 2014;18(4):546-51
46. Geller M, Wagman R, Ho P, et al. Early findings from Prolia® post-marketing safety surveillance for atypical femur fracture, osteonecrosis of the jaw, severe symptomatic hypocalcemia, and anaphylaxis. Ann Rheum Dis 2014;73(Suppl2
47. Bone H, Bolognese M, Yuen C, et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 2008;93(6):2149-57
48. Bone H, Chapurlat R, Brandi M, et al. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metab 2013;11):4483-92
49. Anastasilakis A, Toulis K, Goulis D, et al. Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis. Horm Metab Res 2009;41(10):721-9
50. von Keyserlingk C, Hopkins R, Anastasilakis A, et al. Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis. Semin Arthritis Rheum 2011;41(2):178-86
51. Hageman K, Patel K, Mace K, et al. The role of denosumab for prevention of skeletal-related complications in multiple myeloma. Ann Pharmacother 2013;47(7-8):1069-74
52. Henry D, Costa L, Goldwasser F, et al. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol 2011;29(9):1125-32
53. Watts N, Roux C, Modlin J, et al. Infections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association? Osteoporos Int 2012;23(1):327-37
54. Black D, Cummings S, Karpf D, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996;348(9041):1535-41
55. Black D, Delmas P, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356(18):1809-22