A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density

Journal of Clinical Endocrinology and Metabolism

Volumn 97, Issue 9, 2012, Pages 3161-3169

  Orwoll, Eric ^a   Teglbjærg, Christence S ^b   Langdahl, Bente L ^c   Chapurlat, Roland ^d   Czerwinski, Edward ^e   Kendler, David L ^f   Reginster, Jean Yves ^g   Kivitz, Alan ^h   Lewiecki, E Michael ⁱ   Miller, Paul D ^j   Bolognese, Michael A ^k   McClung, Michael R ^l   Bone, Henry G ^m   Ljunggren, Östen ⁿ   Abrahamsen, Bo ^o   Gruntmanis, Ugis ^p   Yang, Yu Ching ^q   Wagman, Rachel B ^q   Siddhanti, Suresh ^q   Grauer, Andreas ^q   Hall, Jesse W ^q   Boonen, Steven ^r   more..

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b CENTER FOR CLINICAL AND BASIC RESEARCH   (Denmark)

^c AARHUS UNIVERSITY HOSPITAL   (Denmark)

^d UNIVERSITÉ DE LYON   (France)

^e Krakow Medical Center   (Poland)

^f UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^g UNIVERSITY OF LIÈGE   (Belgium)

^h Altoona Center for Clinical Research   (United States)

ⁱ NEW MEXICO CLINICAL RESEARCH AND OSTEOPOROSIS CENTER   (United States)

^j University of Colorado Health Sciences Center   (United States)

^k Bethesda Health Research Center   (United States)

^l OREGON OSTEOPOROSIS CENTER   (United States)

^m Michigan Bone and Mineral Clinic   (United States)

ⁿ UPPSALA UNIVERSITY   (Sweden)

^o UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^p UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^q AMGEN INC   (United States)

^r UNIVERSITY OF LEUVEN   (Belgium)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM; CARBOXY TERMINAL TELOPEPTIDE; COLLAGEN TYPE 1; DENOSUMAB; DRUG ANTIBODY; PLACEBO; TESTOSTERONE; VITAMIN D;

ACUTE PANCREATITIS; ADULT; AGED; ANTIBODY DETECTION; ARTERIAL LIMB THROMBOSIS; ARTERY THROMBOSIS; ARTHRALGIA; ARTICLE; ATYPICAL FEMORAL FRACTURE; BACKACHE; BONE DENSITY; CATARACT; COMPLICATION OF FRACTURE HEALING; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECZEMA; FEMORAL TROCHANTER; FEMUR; FEMUR FRACTURE; FEMUR NECK; FRACTURE NONUNION; FRAGILITY FRACTURE; GENDER; HUMAN; HUMERUS FRACTURE; HYPOCALCEMIA; INFECTION; JAW OSTEONECROSIS; LOW BONE MINERAL DENSITY; LUMBAR SPINE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OSTEOLYSIS; OSTEOPOROSIS; OSTEOPOROTIC FRACTURE RISK; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; PROTEIN BLOOD LEVEL; RADIUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RIB FRACTURE; RISK ASSESSMENT; SIDE EFFECT; SKIN INFECTION; TESTOSTERONE BLOOD LEVEL; TREATMENT DURATION;

ABSORPTIOMETRY, PHOTON; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; BIOLOGICAL MARKERS; BONE AND BONES; BONE DENSITY; BONE REMODELING; DOUBLE-BLIND METHOD; HUMANS; MALE; MIDDLE AGED; TESTOSTERONE;

EID: 84866160239     PISSN: 0021972X     EISSN: 19457197     Source Type: Journal    
DOI: 10.1210/jc.2012-1569     Document Type: Article

References (32)

1. Jones G, Nguyen T, Sambrook PN, Kelly PJ, Gilbert C, Eisman JA 1994 Symptomatic fracture incidence in elderly men and women: the Dubbo Osteoporosis Epidemiology Study (DOES). Osteoporos Int 4:277-282 (Pubitemid 24291436)
2. Gielen E, Vanderschueren D, Callewaert F, Boonen S 2011 Osteoporosis in men. Best Pract Res Clin Endocrinol Metab 25:321-335
3. King AB, Tosteson AN, Wong JB, Solomon DH, Burge RT, Dawson-Hughes B 2009 Interstate variation in the burden of fragility fractures. J Bone Miner Res 24:681-692
4. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A 2007 Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 22:465-475 (Pubitemid 46797130)
5. Johnell O, Kanis JA 2006 An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17:1726-1733 (Pubitemid 44607392)
6. Haentjens P, Magaziner J, Colón-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S 2010 Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med 152:380-390
7. Kannegaard PN, van der Mark S, Eiken P, Abrahamsen B 2010 Excess mortality in men compared with women following a hip fracture. National analysis of comedications, comorbidity and survival. Age Ageing 39:203-209
8. Ebeling PR 2008 Clinical practice. Osteoporosis in men. N Engl J Med 358:1474-1482
9. Kiebzak GM, Beinart GA, Perser K, Ambrose CG, Siff SJ, Heggeness MH2002 Undertreatment of osteoporosis in men with hip fracture. Arch Intern Med 162:2217-2222 (Pubitemid 35231591)
10. Dawson-Hughes B, Looker AC, Tosteson AN, Johansson H, Kanis JA, Melton 3rd LJ 2012 The potential impact of the National Osteoporosis Foundation guidance on treatment eligibility in the USA: an update in NHANES 2005-2008. Osteoporos Int 23:811-820
11. Khosla S, Amin S, Orwoll E 2008 Osteoporosis in men. Endocr Rev 29:441-464 (Pubitemid 351831508)
12. Orwoll E, Ettinger M, Weiss S, Miller P, Kendler D, Graham J, Adami S, Weber K, Lorenc R, Pietschmann P, Vandormael K, Lombardi A 2000 Alendronate for the treatment of osteoporosis in men. N Engl J Med 343:604-610 (Pubitemid 30659471)
13. Boonen S, Orwoll ES, Wenderoth D, Stoner KJ, Eusebio R, Delmas PD 2009 Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. J Bone Miner Res 24:719-725
14. Orwoll ES, Miller PD, Adachi JD, Brown J, Adler RA, Kendler D, Bucci-Rechtweg C, Readie A, Mesenbrink P, Weinstein RS 2010 Efficacy and safety of a once-yearly i.v. infusion of zoledronic acid 5 mg versus a once-weekly 70-mg oral alendronate in the treatment of male osteoporosis: a randomized, multicenter, double-blind, active-controlled study. J Bone Miner Res 25:2239-2250
15. Kurland ES, Cosman F, McMahon DJ, Rosen CJ, Lindsay R, Bilezikian JP 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
16. Cramer JA, Gold DT, Silverman SL, Lewiecki EM 2007 A system-atic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 18:1023-1031 (Pubitemid 47019996)
17. Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J 2008 Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 93:2149-2157 (Pubitemid 351831529)
18. Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C 2009 Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756-765
19. Smith MR, Saad F, Egerdie B, Szwedowski M, Tammela TL, Ke C, Leder BZ, Goessl C 2009 Effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. J Urol 182:2670-2675
20. Genant HK, Wu CY, van Kuijk C, Nevitt MC 1993 Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 8:1137-1148 (Pubitemid 23261108)
21. Meier DE, Orwoll ES, Jones JM 1984 Marked disparity between trabecular and cortical bone loss with age in healthy men. Measurement by vertebral computed tomography and radial photon absorptiometry. Ann Intern Med 101:605-612 (Pubitemid 15223296)
22. Moxness M, Tatarewicz S, Weeraratne D, Murakami N, Wullner D, Mytych D, Jawa V, Koren E, Swanson SJ 2005 Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin Chem 51:1983-1985 (Pubitemid 41368199)
23. Hochberg Y 1988 A sharper Bonferroni procedure for multiple tests of significance. Biometrika 75:800-802
24. Wang C, Nieschlag E, Swerdloff RS, Behre H, Hellstrom WJ, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morales A, Morley JE, Schulman C, Thompson IM, Weidner W, Wu FC 2009 ISA, ISSAM, EAU, EAA and ASA recommendations: investigation, treatment and monitoring of late-onset hypogonadism in males. Aging Male 12:5-12
25. Orwoll ES, Binkley NC, Lewiecki EM, Gruntmanis U, Fries MA, Dasic G 2010 Efficacy and safety of monthly ibandronate in men with low bone density. Bone 46:970-976
26. Dempster DW 2006 Anatomy and functions of the adult skeleton. In: Favus MJ, ed. Primer on the metabolic bone disease and disorders of mineral metabolism. 6th ed. Washington, DC: American Society for Bone and Mineral Research; 7-11
27. Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG 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 24:153-161
28. McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH, Lain D, Kivitz AJ, Holloway DL, Zhang C, Peterson MC, Bekker PJ 2006 Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 354:821-831 (Pubitemid 43290920)
29. Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR 2011 Effect 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 96:394-402
30. Seeman E, Delmas PD, Hanley DA, Sellmeyer D, CheungAM,Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J 2010 Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res 25:1886-1894
31. Melton 3rd LJ, Khosla S, Atkinson EJ, Oconnor MK, Ofallon WM, Riggs BL 2000 Cross-sectional versus longitudinal evaluation of bone loss in men and women. Osteoporos Int 11:592-599
32. Fatayerji D, Cooper AM, Eastell R 1999 Total body and regional bone mineral density in men: effect of age. Osteoporos Int 10:59-65 (Pubitemid 29428016)