Denosumab for treatment of postmenopausal osteoporosis

American Journal of Health-System Pharmacy

Volumn 68, Issue 15, 2011, Pages 1409-1418

  Chitre, Mona ^a   Shechter, David ^b   Grauer, Andreas ^c  

^a Blue Cross and Blue Shield Association   (United States)

^b Scientific Affairs   (United States)

^c AMGEN INC   (United States)

Author keywords

Alendronic acid; Antibodies; Bisphosphonates; Bone density; Denosumab; Fractures; Injections; Mechanism of action; Osteoporosis; Postmenopause; Toxicity

Indexed keywords

25 HYDROXYVITAMIN D; ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; CALCITONIN; CALCIUM; CARBOXY TERMINAL TELOPEPTIDE; DENOSUMAB; ESTROGEN; IBANDRONIC ACID; OSTEOCLAST DIFFERENTIATION FACTOR; OSTEOPROTEGERIN; PARATHYROID HORMONE[1-34]; RALOXIFENE; RECEPTOR ACTIVATOR OF NUCLEAR FACTOR KAPPA B; RISEDRONIC ACID; VITAMIN D; ZOLEDRONIC ACID;

AREA UNDER THE CURVE; BONE DENSITOMETRY; BONE DENSITY; BONE FRAGILITY; BONE MASS; CARDIOVASCULAR DISEASE; CELLULITIS; CHRONIC KIDNEY DISEASE; CHRONIC PAIN; CONCUSSION; COST OF ILLNESS; DISABILITY; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COST; DRUG EFFICACY; DRUG EXPOSURE; DRUG MECHANISM; DRUG SAFETY; DRUG WITHDRAWAL; DUAL ENERGY X RAY ABSORPTIOMETRY; ECZEMA; ERYSIPELAS; FEMUR NECK; FEMUR NECK FRACTURE; FLATULENCE; FOOD AND DRUG ADMINISTRATION; FRAGILITY FRACTURE; GASTROINTESTINAL SYMPTOM; HEALTH CARE SYSTEM; HEART ATRIUM FIBRILLATION; HIGH RESOLUTION COMPUTER TOMOGRAPHY; HIGH RISK PATIENT; HIP FRACTURE; HUMAN; HYPOCALCEMIA; INFECTION; INJECTION SITE REACTION; ISCHEMIC HEART DISEASE; JAW OSTEONECROSIS; LENGTH OF STAY; LUMBAR SPINE; MAXIMUM PLASMA CONCENTRATION; MEDICARE; NEOPLASM; OSTEOCLAST; OSTEOLYSIS; PATIENT COMPLIANCE; PERIPHERAL VASCULAR DISEASE; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RECEPTOR BINDING; REVIEW; RISK BENEFIT ANALYSIS; SPINE FRACTURE; STROKE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT FAILURE; VERTEBRA FRACTURE; VITAMIN BLOOD LEVEL; VITAMIN SUPPLEMENTATION;

EID: 79961122708     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp100493     Document Type: Review

References (47)

1. Clinician's guide to prevention and treatment of osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010:1-36.
2. NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. JAMA. 2001; 285:785-95.
3. Consensus development conference: prophylaxis and treatment of osteoporosis. Am J Med. 1991; 90:107-10.
4. Prolia (denosumab) full prescribing information. Thousand Oaks, CA: Amgen; 2010.
5. Bekker PJ, Holloway DL, Rasmussen AS et al. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004; 19:1059-66. (Pubitemid 41110556)
6. America's bone health: the state of osteoporosis and low bone mass in our nation. Washington, DC: National Osteoporosis Foundation; 2002.
7. Owens G, Jackson R, Lewiecki EM. An integrated approach: bisphosphonate management for the treatment of osteoporosis. Am J Manag Care. 2007; 13 (suppl 11):S290-308.
8. Hasserius R, Karlsson MK, Jonsson B et al. Long-term morbidity and mortality after a clinically diagnosed vertebral fracture in the elderly - a 12- and 22-year follow-up of 257 patients. Calcif Tissue Int. 2005; 76:235-42. (Pubitemid 40991393)
9. 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; 22:465-75. (Pubitemid 46797130)
10. Prevention and management of osteoporosis: WHO technical report series 921. Geneva: World Health Organization; 2003:1-164.
11. Boonen S, McClung MR, Eastell R et al. Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. J Am Geriatr Soc. 2004; 52:1832-9. (Pubitemid 41710266)
12. Shi N, Foley K, Lenhart G et al. Direct healthcare costs of hip, vertebral, and non-hip, non-vertebral fractures. Bone. 2009; 45:1084-90.
13. World Health Organization. FRAX: WHO fracture risk assessment tool. www.shef.ac.uk/FRAX/tool.jsp (accessed 2011 Apr 14).
14. Bone health and osteoporosis: a report of the Surgeon General. Chap. 4. Rockville, MD: Department of Health and Human Services; 2004.
15. Praemer A, Furner S, Rice DP. Musculoskeletal conditions in the United States. 2nd ed. Rosemont, IL: American Academy of Orthopaedic Surgeons; 1992:182.
16. National Committee for Quality Assurance. The state of health care quality: reform, the quality agenda, and resource use. www.ncqa.org/portals/0/ state%20of%20health%20care/2010/SOHC%202010%20-%20Full2.pdf (accessed 2011 Apr 18).
17. Weycker D, Macarios D, Edelsberg J et al. Compliance with drug therapy for postmenopausal osteoporosis. Osteoporos Int. 2006; 17:1645-52. (Pubitemid 44477625)
18. Siris ES, Selby PL, Saag KG et al. Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med. 2009; 122(suppl 2):S3-13.
19. Feldstein AC, Weycker D, Nichols GA et al. Effectiveness of bisphosphonate therapy in a community setting. Bone. 2009; 44:153-9.
20. Boyle WJ, Simonet WS, Lacey DL. Osteoclast differentiation and activation. Nature. 2003; 423(6937):337-42. (Pubitemid 40852708)
21. Lanham-New SA. Importance of calcium, vitamin D and vitamin K for osteoporosis prevention and treatment. Proc Nutr Soc. 2008; 67:163-76. (Pubitemid 351543398)
22. Finkelstein JS, Brockwell SE, Mehta V et al. Bone mineral density changes during the menopause transition in a multiethnic cohort of women. J Clin Endocrinol Metab. 2008; 93:861-8. (Pubitemid 351398564)
23. Fuller K, Wong B, Fox S et al. TRANCE is necessary and sufficient for osteoblast-mediated activation of bone resorption in osteoclasts. J Exp Med. 1998; 188:997-1001. (Pubitemid 28433427)
24. Kong YY, Yoshida H, Sarosi I et al. OPGL is a key regulator of osteoclastogenesis, lymphocyte development and lymph-node organogenesis. Nature. 1999; 397(6717):315-23.
25. Lacey DL, Tan HL, Lu J et al. Osteoprotegerin ligand modulates murine osteoclast survival in vitro and in vivo. Am J Pathol. 2000; 157:435-48. (Pubitemid 30626907)
26. Lacey DL, Timms E, Tan HL et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 1998; 93:165-76. (Pubitemid 28180851)
27. Simonet WS, Lacey DL, Dunstan CR et al. Osteoprotegerin: a novel secreted protein involved in the regulation of bone density. Cell. 1997; 89:309-19. (Pubitemid 27199902)
28. Eghbali-Fatourechi G, Khosla S, Sanyal A et al. Role of RANK ligand in mediating increased bone resorption in early postmenopausal women. J Clin Invest. 2003; 111:1221-30. (Pubitemid 36519939)
29. Peterson M, Stouch B, Martin S. The pharmacokinetics of denosumab (AMG162) following various multiple subcutaneous dosing regimens in postmenopausal women with low bone mass. J Bone Miner Res. 2005; 20(suppl 1). Abstract.
30. Block G, Bone H, Fang L et al. A single dose study of denosumab in patients with various degrees of renal impairment. Presented at National Kidney Foundation Spring Clinical Meeting. Orlando, FL; 2010 Apr.
31. Bone HG, Bolognese MA, Yuen CK et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008; 93:2149-57. (Pubitemid 351831529)
32. Bone H, Bolognese MA, Yuen CK et al. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011; 96:972-80.
33. Miller PD, Bolognese MA, Lewiecki EM 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; 43:222-9.
34. Brown JP, Prince RL, 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; 24:153-61.
35. Cummings SR, San Martin J, McClung MR et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009; 361:756-65.
36. Kendler DL, Roux C, Benhamou CL et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010; 25:72-81.
37. Boonen S, McClung M, Minisola S et al. Effect of denosumab on the incidence of hip, new vertebral, and nonvertebral fractures over 3 years among postmenopausal women with higher fracture risk: a subgroup analysis from the FREEDOM study. www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid= da35831c-de93-4607-8b12-b7fcaf42f45d (accessed 2011 Apr 18).
38. Bock O, Felsenberg D. Bisphosphonates in the management of postmenopausal osteoporosis - optimizing efficacy in clinical practice. Clin Interv Aging. 2008; 3:279-97. (Pubitemid 352037868)
39. Seeman E, Delmas PD, Hanley DA et al. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010; 25:1886-94.
40. Kendler DL, Bessette L, Hill CD et al. Preference and satisfaction with a 6-month subcutaneous injection versus a weekly tablet for treatment of low bone mass. Osteoporos Int. 2010; 21:837-46.
41. Miller PD, Wagman RB, Peacock M et al. Effects of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011; 96:394-402.
42. Chapurlat RD, Papapoulos S, Bone HG et al. Long-term denosumab treatment of postmenopausal women with osteoporosis: results from the first year extension study of the FREEDOM trial. Presented at American College of Rheumatology Annual Scientific Meeting. Atlanta, GA; 2010 Nov.
43. Xgeva (denosumab) full prescribing information. Thousand Oaks, CA: Amgen; 2010.
44. Lindsay R, Silverman SL, Cooper C et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001; 285:320-3. (Pubitemid 32095035)
45. Siris ES, Harris ST, Rosen CJ et al. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin Proc. 2006; 81:1013-22. (Pubitemid 44175011)
46. Reclast (zoledronic acid) full prescribing information. East Hanover, NJ: Novartis Pharmaceuticals; 2009.
47. Boniva Injection (ibandronate sodium) full prescribing information. Nutley, NJ: Roche Laboratories; 2009.