Antirsesorptive treatment of postmenopausal osteoporosis: review of randomized clinical studies and rationale for the Evista alendronate comparison (EVA) trial

References

• NIH Consensus Development Panel on Osteoporosis Prevention Diagnosis and Treatment. Osteoporosis prevention, diagnosis, and therapy. JAMA 2001;285(6):785–95
   PubMed Web of Science ®Google Scholar
• Kanis JA, Melton LJ3, Christiansen C, Johnston CC, Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res 1994;9(8):1137–41
   PubMed Web of Science ®Google Scholar
• America’s Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. 2002. Washington, DC, National Osteoporosis Foundation
   Google Scholar
• Riggs BL, Melton LJ 3d. Involutional osteoporosis. N Engl J Med 1986;314(26):1676–86
   PubMed Web of Science ®Google Scholar
• Cauley J, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int 2000;11(7):556–61
   PubMed Web of Science ®Google Scholar
• Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR. Vertebral fractures and mortality in older women: a prospective study. Study of the Osteoporotic Fractures Research Group. Arch Intern Med 1999;159(11):1215–20
   PubMed Web of Science ®Google Scholar
• Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999;282(14):1344–52
   PubMed Web of Science ®Google Scholar
• McClung M, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344(5):333–40
   PubMed Web of Science ®Google Scholar
• Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, et al. Risk of new vertebral fracture in the year following a fracture. JAMA 2001;285(3):320–3
   PubMed Web of Science ®Google Scholar
• Marcus R, Wong M, Heath H, III, Stock JL. Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocr Rev 2002;23(1):16–37
   PubMed Web of Science ®Google Scholar
• Miller PD, Baran DT, Bilezikian JP, Greenspan SL, Lindsay R, Riggs BL, et al. Practical clinical application of biochemical markers of bone turnover: consensus of an expert panel. J Clin Densitom 1999;2(3):323–42
   PubMed Web of Science ®Google Scholar
• Ross PD, Davis JW, Epstein RS, Wasnich RD. Pre-existing fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med 1991;114(11):919–23
   PubMed Web of Science ®Google Scholar
• Melton LJ, III, Atkinson EJ, O’Fallon WM, Wahner HW, Riggs BL. Long-term fracture prediction by bone mineral assessed at different skeletal sites. J Bone Miner Res 1993;8(10):1227–33
   PubMed Web of Science ®Google Scholar
• Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. Br Med J 1996;312(7041):1254–9
   PubMed Web of Science ®Google Scholar
• Wasnich RD, Miller PD. Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab 2000;85(1):231–6
   PubMed Web of Science ®Google Scholar
• Sarkar S, Mitlak BH, Wong M, Stock JL, Black DM, Harper KD. Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res 2002;17(1):1–10
   PubMed Web of Science ®Google Scholar
• Cummings SR, Black DM, Vogt TM. Changes in BMD substantially underestimate the anti-fracture effects of alendronate and other antiresorptive drugs. J Bone Miner Res 1996;11(Suppl 1):S102
   Google Scholar
• Cummings SR, Black DM, Pearson J, Karpf DB, Harris F, Genant HK, et al. How much of the reduction in risk of vertebral fractures by alendronate is explained by increased spine BMD? J Bone Miner Res 1999;14(Suppl 1):S159
   Google Scholar
• Turner CH. Biomechanics of bone: determinants of skeletal fragility and bone quality. Osteoporos Int 2002;13(2):97–104
   PubMed Web of Science ®Google Scholar
• Lufkin EG, Wahner HW, O’Fallon WM, Hodgson SF, Kotowicz MA, Lane AW, et al. Treatment of postmenopausal osteoporosis with transdermal estrogen. Ann Intern Med 1992;117(1):1–9
   PubMed Web of Science ®Google Scholar
• Windeler J, Lange S. Events per person year – a dubious concept. BMJ 1995;310(6977):454–6
   PubMed Web of Science ®Google Scholar
• Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321–33
   PubMed Web of Science ®Google Scholar
• Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3 year randomized clinical trial. JAMA 1999;282(7):637–45
   PubMed Web of Science ®Google Scholar
• Lufkin EG, Wong M, Deal C. The role of selective estrogen receptor modulators in the prevention and treatment of osteoporosis. Rheum Dis Clin North Am 2001;27(1):163–85, vii
   PubMed Web of Science ®Google Scholar
• Delmas PD, Ensrud KE, Adachi JD, Harper KD, Sarkar S, Gennari C, et al. Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial. J Clin Endocrinol Metab 2002;87(8):3609–17
   PubMed Web of Science ®Google Scholar
• Lufkin EG, Wu W, Wong M, Sarkar S, Pavo I. Raloxifene decreases the relative risk of multiple (> 2) new vertebral fractures in postmenopausal women with osteoporosis: Results from the MORE study. Menopause 2001;8(6):460 [abstract P–21]
   Google Scholar
• Maricic M, Adachi JD, Sarkar S, Wu W, Wong M, Harper KD. Early effects of raloxifene on clinical vertebral fractures at 12 months in postmenopausal women with osteoporosis. Arch Intern Med 2002;162(10):1140–3
   PubMed Web of Science ®Google Scholar
• Delmas PD, Genant HK, Crans G, Wong M, Stock JL, Siris E, et al. Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial. Bone [in press]
   Google Scholar
• Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995;333(22):1437–43
   PubMed Web of Science ®Google Scholar
• Black DM, Cummings SR, Karpf DB, Cauley J, Thompson DE, Nevitt MC, 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
   PubMed Web of Science ®Google Scholar
• Cummings S, Black D, Thompson DE, Applegate WB, Barrett-Connor E, Musliner T, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. JAMA 1998;280:2077–82
   PubMed Web of Science ®Google Scholar
• Black DM, Thompson DE, Bauer DC, Ensrud K, Musliner T, Hochberg MC, et al. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 2000;85(11):4118–24
   PubMed Web of Science ®Google Scholar
• Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 2000;11(1):83–91
   PubMed Web of Science ®Google Scholar
• Heaney RP, Zizic TM, Fogelman I, Olszynski WP, Geusens P, Kasibhatla C, et al. Risedronate reduces the risk of first vertebral fracture in osteoporotic women. Osteoporos Int 2002;13(6):501–5
   PubMed Web of Science ®Google Scholar
• Chesnut CH, III, Silverman S, Andriano K, Genant H, Gimona A, Harris S, et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group. Am J Med 2000;109(4):267–76
   PubMed Web of Science ®Google Scholar
• Cranney A, Guyatt G, Griffith L, Wells G, Tugwell P, Rosen C. Meta-analyses of therapies for postmenopausal osteoporosis. IX: Summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 2002;23(4):570–8
   PubMed Web of Science ®Google Scholar
• Bone HG, Greenspan SL, McKeever C, Bell N, Davidson M, Downs RW, et al. Alendronate and estrogen effects in postmenopausal women with low bone mineral density. Alendronate/Estrogen Study Group. J Clin Endocrinol Metab 2000;85(2):720–6
   PubMed Web of Science ®Google Scholar
• Ravn P, Bidstrup M, Wasnich RD, Davis JW, McClung MR, Balske A, et al. Alendronate and estrogen-progestin in the long-term prevention of bone loss: four-year results from the early postmenopausal intervention cohort study. A randomized, controlled trial. Ann Intern Med 1999;131(12):935–42
   PubMed Web of Science ®Google Scholar
• Dursun N, Dursun E, Yalcin S. Comparison of alendronate, calcitonin and calcium treatments in postmenopausal osteoporosis. Int J Clin Pract 2001;55(8):505–9
   PubMed Web of Science ®Google Scholar
• Downs RW, Jr., Bell NH, Ettinger MP, Walsh BW, Favus MJ, Mako B, et al. Comparison of alendronate and intranasal calcitonin for treatment of osteoporosis in postmenopausal women. J Clin Endocrinol Metab 2000;85(5):1783–8
   PubMed Web of Science ®Google Scholar
• Prestwood KM, Gunness M, Muchmore DB, Lu Y, Wong M, Raisz LG. A comparison of the effects of raloxifene and estrogen on bone in postmenopausal women. J Clin Endocrinol Metab 2000;85(6):2197–202
   PubMed Web of Science ®Google Scholar
• Tsai KS, Yen ML, Pan HA, Wu MH, Cheng WC, Hsu SH, et al. Raloxifene versus continuous combined estrogen/progestin therapy: densitometric and biochemical effects in healthy postmenopausal Taiwanese women. Osteoporos Int 2001;12(12):1020–5
   PubMed Web of Science ®Google Scholar
• Johnell O, Scheele WH, Lu Y, Reginster J-Y, Need AG, Seeman E. Additive effects of raloxifene and alendronate on bone density and biochemical markers of bone remodeling in postmenopausal women with osteoporosis. J Clin Endocrinol Metab 2002;87(3):985–92
   PubMed Web of Science ®Google Scholar
• Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med 1998;128:793–800
   PubMed Web of Science ®Google Scholar
• Ettinger B, Black DM, Nevitt MC, Rundle AC, Cauley JA, Cummings SR, et al. Contribution of vertebral deformities to chronic back pain and disability. The Study of Osteoporotic Fractures Research Group. J Bone Miner Res 1992;7(4):449–56
   PubMed Web of Science ®Google Scholar
• Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 1993;8(9):1137–48
   PubMed Web of Science ®Google Scholar
• Looker AC, Johnston CC, Jr., Wahner HW, Dunn WL, Calvo MS, Harris TB, et al. Prevalence of low femoral bone density in older U.S. women from NHANES III. J Bone Miner Res 1995;10(5):796–802
   PubMed Web of Science ®Google Scholar
• Wong M, Sarkar S, Harper K. Raloxifene therapy for 4 years decreases incidence of new vertebral fractures in postmenopausal women with osteoporosis. Menopause 2002;9(6):490 [abstract P–47]
   Google Scholar