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Review

Non-vertebral fracture risk reduction with oral bisphosphonates: challenges with interpreting clinical trial data

Pages 107-119 | Accepted 26 Oct 2007, Published online: 19 Nov 2007

References

  • Watts NB, Harris ST, Genant HK, et al. Intermittent cyclical etidronate treatment of postmenopausal osteoporosis. N Engl J Med 1990;323:73–79
  • Storm T, Thamsborg G, Steiniche T, et al. Effect of intermittent cyclical etidronate therapy on bone mass and fracture rate in women with postmenopausal osteoporosis. N Engl J Med 1990;322:1265–71
  • Dargent-Molina P, Favier F, Grandjean H, et al. Fall-related factors and risk of hip fracture: the EPIDOS prospective study. Lancet 1996;348:145–9
  • Chen YT, Miller PD, Barrett-Connor E, et al. An approach for identifying postmenopausal women age 50–64 years at increased short-term risk for osteoporotic fracture. Osteoporos Int 2007. Epub ahead of print
  • Delmas PD, Genant HK, Crans GG, et al. Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial. Bone 2003;33:522–32
  • Johnell O, Oden A, Caulin F, et al. Acute and long-term increase in fracture risk after hospitalization for vertebral fracture. Osteoporos Int 2001;12:207–14
  • Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA 2001;285:320–3
  • Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ 1996;312:1254–9
  • Melton LJ, III. Vertebral fractures predict subsequent fractures. Osteoporos Int 1999;10:214–21
  • Marcus R, Wong M, Heath H, et al. Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocr Rev 2002;23:16–37
  • Black DM, Cummings SR, Karpf DB, 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;348:1535–41
  • Chesnut CH, 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;19:1241–9
  • Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998;280:2077–82
  • Harris ST, Watts NB, Genant HK, 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;282:1344–52
  • Reginster JY, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000;11:83–91
  • Siris ES, Brenneman SK, Barrett-Connor E, et al. The effect of age and bone mineral density on the absolute, excess, and relative risk of fracture in postmenopausal women aged 50–99: results from the National Osteoporosis Risk Assessment (NORA). Osteoporos Int 2006;17: 565–74
  • van Staa TP, Leufkens HG, Cooper C. Does a fracture at one site predict later fractures at other sites? A British cohort study. Osteoporos Int 2002;13:624–9
  • Cauley JA, Thompson DE, Ensrud KC, et al. Risk of mortality following clinical fractures. Osteoporos Int 2000;11:556–61
  • Johnell O, Kanis JA, Oden A, et al. Mortality after osteoporotic fractures. Osteoporos Int 2004;15:38–42
  • Chrischilles EA, Butler CD, Davis CS, et al. A model of lifetime osteoporosis impact. Arch Intern Med 1991;151:2026–32
  • Lips P. Invest in your bones: Quality of Life. Why prevent the first fracture? International Osteoporosis Foundation 2003
  • National Osteoporosis Foundation. Fast facts. 2002. Available from: URL: http://www.nof.org/osteoporosis/diseasefacts.htm
  • Asthma and Allergy Foundation of America. Asthma Facts and Figures. 2000. Available from: URL: http://www.aafa.org/display.cfm?id=8&sub=42
  • Cooper C, Campion G, Melton LJ, III. Hip fractures in the elderly: a world-wide projection. Osteoporos Int 1992;2:285–9
  • Johnell O. The socioeconomic burden of fractures: today and in the 21st century. Am J Med 1997;103:20S–5S
  • International Osteoporosis Foundation. Osteoporosis in the workplace. 2002. Available from: URL: http://www.iofbonehealth.org/publications/workplace-report.html
  • Miller PD, Bilezikian JP, Deal C, et al. Clinical use of teriparatide in the real world: initial insights. Endocr Pract 2004;10:139–48
  • Hodsman AB, Bauer DC, Dempster DW, et al. Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use. Endocr Rev 2005;26:688–703
  • Liberman UA, Weiss SR, Broll J, 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;333:1437–43
  • McClung MR, Geusens P, Miller PD, et al. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 2001;344:333–40
  • Pols HA, Felsenberg D, Hanley DA, et al. Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group. Osteoporos Int 1999;9:461–8
  • Miller PD. Bisphosphonates: Pharmacology and Use in Osteoporosis. In: Marcus R, Feldman D, Rosen C, Nelson D, eds. Osteoporosis, 3rd edn. Philadelphia: Lippincott, Williams & Wilkins, 2007.
  • Nancollas GH, Tang R, Phipps RJ, et al. Novel insights into actions of bisphosphonates on bone: differences in interactions with hydroxyapatite. Bone 2006;38:617–27
  • Russell RG, Rogers MJ. Bisphosphonates: from the laboratory to the clinic and back again. Bone 1999;25:97–106
  • FDA. Guidelines for preclinical and clinical evaluation of agents in the prevention and treatment of postmenopausal osteoporosis. 1994
  • Delmas PD, Calvo G, Boers M, et al. The use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis. Osteoporos Int 2002;13:1–5
  • Brandi ML, Harrington TJ, Barton I, et al. Risedronate reduced the risk of nonvertebral fractures as soon as 6 months in post menopausal osteoporosis. J Bone Miner Res 2002;17(Suppl 1):S270
  • Black DM, Delmas PD, Eastell R, et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356:1809–22
  • Boonen S, Laan RF, Barton IP, et al. Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies. Osteoporos Int 2005;16:1291–8
  • Papapoulos SE, Schimmer RC. Changes in bone remodelling and antifracture efficacy of intermittent bisphosphonate therapy: implications from clinical studies with ibandronate. Ann Rheum Dis 2007;66:853–8
  • Schnitzer T, Bone HG, Crepaldi G, et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano) 2000;12:1–12
  • Brown JP, Kendler DL, McClung MR, et al. The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis.Calcif Tissue Int 2002;71:103–11
  • Cranney A, Wells G, Adachi R. Non-vertebral fracture reduction with high- versus low-dose ibandronate: a meta-analysis of individual patient data. Ann Rheum Dis 2007;66(Suppl. 2):681 (Abstract LB0004)
  • Miller PD, McClung MR, Macovei L, et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 2005;20:1315–22
  • Delmas PD, Adami S, Strugala C, et al. Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study. Arthritis Rheum 2006;54:1838–46
  • Miller PD, Harris ST, Blumentals WA. Clinical and nonvertebral fracture risk is reduced with the use of ibandronate in women with postmenopausal osteoporosis. J Bone Miner Res 2007;22(Suppl. 1):S451 (Abstract W355)

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