Denosumab significantly increases DXA BMD at both trabecular and cortical sites: Results from the FREEDOM study

Journal of Clinical Densitometry

Volumn 16, Issue 2, 2013, Pages 147-153

  Bolognese, Michael A ^a   Teglbjærg, Christence Stubbe ^b   Zanchetta, Jose R ^c   Lippuner, Kurt ^d   McClung, Michael R ^e   Brandi, Maria Luisa ^f   Høiseth, Arne ^g   Lakatos, Péter ^h   Moffett, Alfred H ⁱ   Lorenc, Roman S ^j   Wang, Andrea ^k   Libanati, Cesar ^k  

^a Bethesda Health Research Center   (United States)

^b CENTER FOR CLINICAL AND BASIC RESEARCH   (Denmark)

^c Instituto de Investigaciones Metabolicas   (Argentina)

^d UNIVERSITY OF BERN   (Switzerland)

^e OREGON OSTEOPOROSIS CENTER   (United States)

^f UNIVERSITY OF FLORENCE   (Italy)

^g Curato Røntgeninstitutt   (Norway)

^h SEMMELWEIS UNIVERSITY   (Hungary)

ⁱ OB GYN Associates of Mid Florida   (United States)

^j Child Health Institute   (Poland)

^k AMGEN INC   (United States)

more..

Author keywords

Bone mineral density; Denosumab; DXA; Osteoporosis

Indexed keywords

DENOSUMAB; PLACEBO;

AGED; ARTICLE; BODY MASS; BONE DENSITY; CONTROLLED STUDY; CORTICAL BONE; DRUG EFFECT; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; FEMUR NECK; FRACTURE; GREATER TROCHANTER; HIP; HUMAN; LUMBAR SPINE; MAJOR CLINICAL STUDY; OSTEOPOROSIS; POSTMENOPAUSE; PRIORITY JOURNAL; RADIUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SPINE; TRABECULAR BONE;

ABSORPTIOMETRY, PHOTON; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; BONE DENSITY; FEMALE; FEMUR NECK; HUMANS; LUMBAR VERTEBRAE; OSTEOPOROSIS, POSTMENOPAUSAL; OSTEOPOROTIC FRACTURES; RANK LIGAND;

EID: 84877074012     PISSN: 10946950     EISSN: 15590747     Source Type: Journal    
DOI: 10.1016/j.jocd.2012.02.006     Document Type: Article

References (29)

1. Lacey D.L., Tan H.L., Lu J., et al. Osteoprotegerin ligand modulates murine osteoclast survival in vitro and in vivo. Am J Pathol 2000, 157:435-448.
2. Lacey D.L., Timms E., Tan H.L., et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell 1998, 93:165-176.
3. Udagawa N., Takahashi N., Yasuda H., et al. Osteoprotegerin produced by osteoblasts is an important regulator in osteoclast development and function. Endocrinology 2000, 141:3478-3484.
4. Yasuda H., Shima N., Nakagawa N., et al. Osteoclast differentiation factor is a ligand for osteoprotegerin/osteoclastogenesis-inhibitory factor and is identical to TRANCE/RANKL. Proc Natl Acad Sci USA 1998, 95:3597-3602.
5. Brown J.P., Prince R.L., 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, 24:153-161.
6. Reid I.R., Miller P.D., Brown J.P., et al. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res 2010, 25:2256-2265.
7. McClung M.R., Lewiecki E.M., Cohen S.B., et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006, 354:821-831.
8. Bone H.G., Bolognese M.A., Yuen C.K., et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab 2008, 93:2149-2157.
9. Cummings S.R., San Martin J., McClung M.R., et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 2009, 361:756-765.
10. Prolia® (denosumab) Prescribing Information Version 2 (July 2011). Amgen Inc., Thousand Oaks, CA. Available at: Accessed: December 8, 2011. http://pi.amgen.com/united_states/prolia/prolia_pi.pdf.
11. Prolia® (denosumab). Summary of Product Characteristics. Amgen Inc., Europe. Available at: Accessed: December 8, 2011. http://ec.europa.eu/health/documents/community-register/2010/2010052679008/anx_79008_en.pdf.
12. Lorente-Ramos R., Azpeitia-Arman J., Munoz-Hernandez A., et al. Dual-energy x-ray absorptiometry in the diagnosis of osteoporosis: a practical guide. AJR Am J Roentgenol 2011, 196:897-904.
13. Hans D.B., Shepherd J.A., Schwartz E.N., et al. Peripheral dual-energy X-ray absorptiometry in the management of osteoporosis: the 2007 ISCD Official Positions. J Clin Densitom 2008, 11:188-206.
14. Blake G.M., Fogelman I. Role of dual-energy X-ray absorptiometry in the diagnosis and treatment of osteoporosis. J Clin Densitom 2007, 10:102-110.
15. Theodorou D.J., Theodorou S.J., Sartoris D.J. Dual-energy X-ray absorptiometry in diagnosis of osteoporosis: basic principles, indications, and scan interpretation. Compr Ther 2002, 28:190-200.
16. Orwoll E.S., Miller P.D., Adachi J.D., et al. 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 2010, 25:2239-2250.
17. Reid D.M., Devogelaer J.P., Saag K., et al. Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet 2009, 373:1253-1263.
18. Eastell R., Christiansen C., Grauer A., et al. Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J Bone Miner Res 2011, 26:530-537.
19. Marcus R., Feldman D., Kelsey J. Osteoporosis 1996, Academic Press, Inc, San Diego, CA. 1st edn.
20. Seeman E., Delmas P.D., Hanley D.A., et al. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res 2010, 25:1886-1894.
21. Genant H.K., Engelke K., Hanley D.A., et al. Denosumab improves density and strength parameters as measured by QCT of the radius in postmenopausal women with low bone mineral density. Bone 2010, 47:131-139.
22. McClung M., Lewiecki E.M., Bolognese M.A., et al. Effects of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial [abstract 1061]. J Bone Miner Res 2011, 24(Suppl 1):S20.
23. Miller P.D., Bolognese M.A., Lewiecki E.M., 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, 43:222-229.
24. Miller P.D., Wagman R.B., Peacock M., et al. 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 2011, 96:394-402.
25. Seeman E., Libanati C., Austin M., et al. The transitory increase in PTH following denosumab administration is associated with reduced intracortical porosity: a distinctive attribute of denosumab therapy [abstract 1064]. J Bone Miner Res 2011, 24(Suppl 1):S22.
26. Brown J., Beck Jensen J.-E., Recknor C., et al. The analysis of denosumab discontinuation and associated fracture incidence in the FREEDOM trial. Arthritis Rheum 2011, 63:S428.
27. Boonen S., Adachi J.D., Man Z., et al. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 2011, 96:1727-1736.
28. Simon J., Recknor C., Moffett A.H., et al. Effects of denosumab on radius BMD, strength, and wrist fractures: results from the fracture reduction evaluation of denosumab in osteoporosis every 6 months (FREEDOM) study [abstract 1062]. J Bone Miner Res 2011, 24(Suppl 1):S20.
29. Austin M., Yang Y.C., Vittinghoff E., et al. Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures. J Bone Miner Res 2011, 27:687-693.