References
Albright F, Smith PH, Richardson AM (1941) Postmenopausal osteoporosis. JAMA 116:2465–2474
Kanis JA, Oden A, Johnell O, De Laet C, Jonsson B, Oglesby AK (2003) The components of excess mortality after hip fracture. Bone 32:468–473, Kanis JA, Johnell O, Oden A, De Laet C, Jonsson B, Dawson A. Ten year risk of osteoporotic fracture and the effect of risk factors on screening strategies. Bone 2002;30:251–8
Melton LJ, Gabriel SE, Crowson CS, Tosteson ANA, Johnell O, Kanis JA (2003) Cost equivalence of different osteoporotic fractures. Osteoporosis International 14:383–388
Kanis JA, Oden A, Johnell O, Jonsson B, de Laet C, Dawson A (2001) The burden of osteoporotic fractures: a method for setting intervention thresholds. Osteoporosis International 12:417–427
Siris ES, Chen YT, Abbott TA, Barrett-Connor E, Miller PD, Wehren LE, Berger ML (2004) Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Intern Med 164:1108–1112
Sanders K, Nicholson G, Watts J et al (2006) Half the burden of fragility fractures in the community occur in women without osteoporosis. When is fracture prevention cost effective? Bone 38:694–700
Sornay-Rendu E, Munoz F, Garnero P, Duboeuf F, Delmas PD (2005) The identification of osteopenic women at high risk of fracture: the OFELY Study. J Bone Miner Res 20:1929–1934
Population Division of the Department of Economic and Social Affairs of the Nations Secretariat 2002 World Population Prospects: The 2002 Revision and World Urban Prospects. Online http://esa.un.org/unpp. Accessed January 2006
Seeman E, Bianchi G, Khosla S, Kanis JA, Orwoll E (2006) Bone fragility in men-where are we? Osteoporos Int 17:1577–1583
Compston JE, Seeman E (2006) Compliance with osteoporosis therapy is the weakest link. Lancet 368:973–974
Delmas PD (2002) Treatment of postmenopausal osteoporosis. Lancet 359:2018–2026
Black DM, Boonen S, Cauley J et al (2006) Effect of once-yearly infusion of zoledronic acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON pivotal fracture trial. J Bone Mineral Res 21(suppl 1):s1–s530[1054]
Reginster JY, Seeman E, De Vernejoul MC, Adami S, Compston J, Phenekos C, Devogelaer JP, Curiel MD, Sawicki A, Goemaere S, Sorensen OH, Felsenberg D, Meunier PJ (2005) Strontium ranelate reduces the risk of non vertebral fractures in postmenopausal women with osteoporosis: TReatment Of Peripheral OSsteoporosis (TROPOS) Study. J Clin Endoc Metab 90:2816–2822
Sato Y, Iwamoto J, Kanoko T, Satoh K (2005) Risedronate therapy for prevention of hip fracture after stroke in elderly women. Neurology 64:811–816
Sato Y, Kanoko T, Satoh K, Iwamoto J (2005) The prevention of hip fracture with risedronate and ergocalciferol plus calcium supplementation in elderly women with Alzheimers Disease. A randomized controlled trial. Arch Intern Med 165:1737–1742
Sato Y, Iwanmoto J, Kanok T, Satoh K (2005) Risedronate sodium therapy for prevention of hip fracture in men 65 years or older after stroke. Arch Intern Med 165:1743–1748
Black DM, Thompson DE, Bauer DC et al (2000) FIT Re-search Group. Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. J Clin Endocrinol Metab 85:4118–4124
Jackson RD, LaCroix AZ, Gass M et al (2006) for the Women’s Health Initiative Investigators. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med 354:669–683
Prince RL, Devine A, Dhaliwal SS, Dick IM (2006) Effects of calcium supplementation on clinical fracture and bone structure results of a 5-year, double-blind, placebo-controlled trial in elderly women. Arch Intern Med 166:869–875
Reid IR, Mason B, Horne A, Ames R, Reid HE, Bava U, Bolland MJ, Gamble GD (2006) Randomized controlled trial of calcium in healthy older women Amer J Med 119:777–785
Kanis JA, Johnell O, Black DM et al (2003) Effect of raloxifene on the risk of new vertebral fracture in postmenopausal women with osteopenia or osteoporosis: a reanalysis of the Multiple Outcomes of Raloxifene Evaluation trial. Bone 33:293–300
Seeman E, Devogelaer JP, Lorenc RS, Spector T, Brixen K, Vellas B, Balogh A, Stucki G, Meunier PJ, Reginster JY (2004) Strontium ranelate: the first anti-osteoporotic agent to reduce the risk of vertebral fracture in patients with lumbar osteopenia. IOF World Congress on Osteoporosis, Rio de Janeiro, 14–18, May, OC45
Quandt SA, Thompson DE, Schneider DL et al (2005) Fracture Intervention Trial Research Group. Effect of alendronate on vertebral fracture risk in women with bone mineral density T scores of −1.6 to −2.5 at the femoral neck: the Fracture Intervention Trial. Mayo Clin Proc 80:343–349
Laupacis A, Sackett DL, Roberts RS (1988) An assessment of clinically useful measures of the consequences of treatment. New Engl J Med 318:1728–1733
Boonen S, McClung MR, Eastell R, Fuleihan GE-H, Barton IP, Delmas PD (2004) 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. JAGS 52:1832–1839
Boonen S, Marin F, Mellstrom M, Xie L, Desaiah D, Krege JH, Rosen CJ (2006) Safety and efficacy of teriparatide in elderly women with established osteoporosis: Bone anabolic therapy from a geriatric Perspective. JAGS
Seeman E, Vellas B, Benhamou C, Aquino JP, Semler J, Kaufman JM, Hoszowski, RoceVarel AR, Fiore C, Brixen K, Reginster JY, Boonen S (2006) Strontium ranelate reduces the risk of vertebral and non-vertebral fractures in women aged eighty years and over. J Bone Miner Res 21:1113–1120
Guyatt GH, Crabbey A, Griffith L, Walters S, Krolicki N, Favus M, Rosen C (2002) Summary of meta analyses of therapies for postmenopausal osteoporosis and the relationship between bone density and fractures. Endocrinol Metab Clin North Am 31:656–670
Kanis JA, Oden A, Hohnell O, Caulin F, Bone H, Alexandre JM, Abadie E, Lekkerkerker F (2002) Uncertain future of trials in osteoporosis. Osteoporos Int 13:443–449
Reginster J-Y, Abadie E, Delmas PD, Rizzoli R, Dere W, der Auwera P, Avouac B, Brandi ML, Daifotis A, Diez-Perez A, Calvo G, Johnell O, Kaufman J-M, Kreutz G, Laslop A, Lekkerkerker F, Mitlak B, Nilsson P, Orloff J, Smillie M, Taylor A, Tsouderos Y, Ethgen D, Flamion B (2006) Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men. Osteoporos Int 17:1–7
Committee for medicinal products for human use (CHMP). Guidelines on the evaluation of medicinal products in the treatment of primary osteoporosis. Lond 16 Nov 2006 CPMP/EWP/552/95 Rev.2
Delmas PD, Seeman E (2004) Changes in bone mineral density explain little of the reduction in vertebral or nonvertebral fracture risk with anti-resorptive therapy. Bone 34:599–604
Bauer DC, Garnero P, Hochberg MC, Santora A, Delmas P, Ewing SK, Black DM (2006) Pretreatment levels of bone turnover and the antifracture efficacy of alendronate: the fracture intervention trial. J Bone Miner Res 21:292–299
Perel P, Roberts I, Sena E, Wheble P, Briscoe C, Sandercock P, Macleod M, Mignini LE, Jayaram P, Khan KS (2006) Comparison of treatment effects between animal experiments and clinical trials: systematic review. BMJ. Dec 15 on line DOI 10.1136/bmj.39048.407928.BE
Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892
Writing Group for the Women’s Health Initiative Investigators (2002) Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomised controlled trial. JAMA 288:321–333
Seeman E, Delmas PD (2006) Bone Quality; the material and structural basis of bone strength. N Engl J Med 354:2250–2261
Black DM, Schwarz AW, Ensrud KE et al (2006) Effects of continuing or stopping alendronate after 5 years of treatment. JAMA 296:2927–2938
Prince R, Sipos A, Hossain A, Syversen U, Ish-Shalom S, Marcinowska E, Halse J, Lindsay R, Dalsky GP, Mitlak BM (2005) Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment. J Bone Miner Res 20:1507–1513
Mellstrom DD, Sorensen OH, Goemaere S, Roux C, Johnson TD, Chines AA (2004) Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcif Tissue Int 75:462–468
Bone HG, Hosking D, Devogelaer J-P, Tucci JR, Emkey RD, Yonino RP, RodriguezPortales JA, Downs RW, Gupta J, ACSantora, Liberman UA (2004) Ten years experience with alendronate for osteoporosis in postmenopausal women. N Eng J Med 350:1189–1199
Mashiba T, Hirano T, Turner CH, Forwood MR, Johnston CC, Burr DB (2000) Suppressed bone turnover by bisphosphonates increases microdamage accumulation and reduces some biomechanical properties in dog rib. J Bone Miner Res 15:613–620
Odvina CV, Zerwekh JE, Rao DS, Maaloof N, Gottschalk FA, Pak CYC (2005) Severly suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab 1294–1301
Bilezikian JP (2006) Osteonecrosis of the jaw–do bisphosphonates pose a risk? N Engl J Med 30;355:2278–2281
Whyte MP, Wenkert D, Clements KL, McAlister WH, Mumm S (2003) Brief report: bisphosphonare-dinduced osteopetrosis. New Engl J Med 349:457–463
Seeman E, Compston J. Adachi J, Brandi ML, Cooper C, Dawson-Hughes B, Jönsson B, Pols H, Cramer JA. Non-compliance: the Achilles’ heel of anti-fracture efficacy. In press Osteoporosis Int
Boutroy S, Bouxsein ML, Munoz F, Delmas PDD (2005) In vivo assessment of trabecular microarchitecture by high-resolution peripheral quantitative computed tomography. J Clin Endocriol Metab 90:6508–6515
Bouxsein ML, Melton LJ, Riggs BL, Muller J, Atkinson EJ, Oberg AL, Robb RA, Camp JJ, Rouleau PA, McCollough CH, Khosla S (2006) Age- and sex-specific differences in the factor of risk for vertebral fracture: a population-based study using QCT. J Bone Miner Res 21:1475–1482
Johnell O, Kanis JA (2006) An estimate of the world-wide prevalence and disability associated with osteoporotic fractures. Osteoporosis International 17:1726–1733
Garnero P, Delmas PD (2004) Contribution of bone mineral density and bone turnover markers to the estimation of risk of osteoporotic fracture in postmenopausal women. J Musculoskel Neiuron Interact 4:50–63
Martin TJ, Seeman E (2006) New mechanisms and targets in the treatment of bone fragility. Clin Science 112:77–91
McClung MR, Lewiecki EM, Cohen SB et al (2006) Denosumab in postmenopausal women with low bone mineral density. New Engl J Med 354:821–831
Adami S, Supronik J, Hala T et al (2006) Effect of one year treatment with the Cathepsin-K Inhibitor, Balicatib, on bone mineral density (BMD) in postmenopausal women with osteopenia/osteoporosis. J Bone Mineral Res 21(suppl 1):s1–s530[1085]
Papanastasiou P, Ortmann CE, Olson M et al (2006) Effect of Three Month Treatment with the cathepsin-K inhibitor, balicatib, on biochemical markers of bone turnover in postmenopausal women: evidence for uncoupling of bone resorption and bone formation. J Bone Mineral Res 21(suppl 1):s1–s530[1223]
Rose G (2001) Sick individuals and sick populations. Int J Epidemiol 30:427–432
Kronhed A-C G, Blomberg C, Karlsson N, Lofman O, Tmpka T, Moller M (2005) Impact of a community-based osteoporosis and fall prevention program on fracture incidence. Osteoporos Int 16:700–706
Melton LJ, Atkinson EJ, Madbok R (1996) Downturn in hip fracture incidence. Public Health Reports 111:146–150
Newman ED, Ayoub WT, Starkey RH, Diehl JM, Wood GC (2003) Osteoporosis disease management in a rural health care population: hip fracture reduction and reduced costs in postmenopausal women after 5 years. Osteoporos Int 14:146–151
Melton LJ, Kanis JA, Johnell O (2005) Potential impact of osteoporosis treatment on hip fracture trends. J Bone Miner Res 20:895–897
Eliot TS, The Wasteland
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Seeman, E. Unmet needs in fracture prevention: new European guidelines for the investigation and registration of therapeutic agents. Osteoporos Int 18, 569–573 (2007). https://doi.org/10.1007/s00198-007-0350-z
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DOI: https://doi.org/10.1007/s00198-007-0350-z