Supplements Fracture Prevention in Osteoporosis
Importance of Early Diagnosis and Treatment of Osteoporosis to Prevent Fractures
Hormone Therapy: Hormone therapy (HT) is a long-established approach for the prevention and treatment of osteoporosis. Recent results from the Women's Health Initiative, which enrolled almost 11 000 postmenopausal women beginning in 1993, found that HT resulted in a reduction of 39%, 38%, and 30% in hip, vertebral, and total fractures, respectively, versus placebo.51 Unfortunately, a concurrent increase in the incidence of cardiovascular events, chiefly stroke, has cast a serious shadow over the future of HT as an option in the management of osteoporosis.
For managed healthcare, significant opportunities exist for reducing the costs of osteoporosis-related fractures by improving follow-up treatment for fractures and identifying other individuals with osteoporosis at high risk for fracture. Treatment of postfracture patients has been shown to be far less adequate than would be expected in such a high-risk group. Enhanced treatment in this easily identifiable group should yield substantially improved downstream clinical outcomes. A more daunting task, perhaps, is the identification of other groups at high-risk for fracture. BMD, as measured by T-scores, has demonstrated some correlation with fracture risk. Clearly, the preponderance of clinical evidence now requires a consideration of other risk factors–age, prior fracture, glucocorticoid use among others, in addition to BMD, as a means of assessing fracture risk. Administrative claims databases may provide a valuable source of patient information for screening. As a result of the Medicare Modernization Act of 2003, there may be an increased number of patients at risk for osteoporosis enrolling in Medicare Advantage health plans, heightening the importance of effective preventive measures and treatments, with a focus on high-risk populations to improve outcomes. To provide optimal management and cost effectiveness, patients at high risk for fracture will require the use of agents that not only impact BMD but also have demonstrated efficacy in reducing both vertebral and nonvertebral fractures as a major component of a proactive management plan.
Corresponding author: Joseph R. Tucci, MD, Chief, Division of Endocrinology, Roger Williams Medical Center, Providence, Rhode Island. E-mail: email@example.com.
1. National Osteoporosis Foundation. Physician's Guide: Pharmacologic Options. Available at: http://www.nof.org/physguide/pharmacologic.htm. Accessed February 23, 2006.
2. Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey. Available at: http://www.cdc.gov/nchs/data/nhanes/databriefs/osteoporosis.pdf. Accessed February 23, 2006.
3. MedPAC. Medicare Beneficiary Demographics. Available at: http://www.medpac.gov/publications/congressional_reports/Jun04DataBookSec1.pdf. Accessed February 23, 2006.
4. Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med. 1997;103:12S-17S; discussion 17S-19S.
5. Seeman E, Eisman JA. Treatment of osteoporosis: why, whom, when and how to treat. The single most important consideration is the individual's absolute risk of fracture. Med J Aust. 2004;180:298-303.
6. NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy. JAMA. 2001;285:785-795.
7. Heart Disease and Stroke Statistics-2003 Update. American Heart Association. 2003.
8. Green AD, Colon-Emeric CS, Bastian L, Drake MT, Lyles KW. Does this woman have osteoporosis? JAMA. 2004;292:2890-2900.
9. Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11:556-561.
10. American Medical Association. Osteoporosis Management. Pathophysiology of Osteoporosis. Available at: http://www.ama-cmeonline.com/osteo_mgmt/module03/01cme/02.htm. Accessed February 23, 2006.
11. Rosen CJ, Tenenhouse A. Biochemical markers of bone turnover. A look at laboratory tests that reflect bone status. Postgrad Med. 1998;104:101-102, 107-110,113-114.
12. Klotzbuecher CM, Ross PD, Landsman PB, Abbott TA III, Berger M. Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Miner Res. 2000;15:721-739.
13. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001;285:320-323.
14. Acheson LS. Bone density and the risk of fractures: should treatment thresholds vary by race? JAMA. 2005;293:2151-2154.
15. South-Paul JE. Osteoporosis: part I. Evaluation and assessment. Am Fam Physician. 2001;63:897-904, 908.
16. National Osteoporosis Foundation. Reimbursement of Bone Mineral Density Test. Available at: http://www.nof.org/professionals/reimbursement/. Accessed February 23, 2006.
17. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA. 2001;286:2815-2822.
18. Siris ES, Chen YT, Abbott TA, et al. Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Intern Med. 2004;164:1108-1112.
19. Riggs BL, Wahner HW, Dunn WL, Mazess RB, Offord KP, Melton LJ III. Differential changes in bone mineral density of the appendicular and axial skeleton with aging: relationship to spinal osteoporosis. J Clin Invest. 1981;67:328-335.
20. Miller PD, Bonnick SL, Rosen CJ, et al. Clinical utility of bone mass measurements in adults: consensus of an international panel. The Society for Clinical Densitometry. Semin Arthritis Rheum. 1996;25:361-372.
21. Cummings SR, Nevitt MC, Browner WS, et al. Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med. 1995;332:767-773.
22. Dargent-Molina P, Favier F, Grandjean H, et al. Fall-related factors and risk of hip fracture: the EPIDOS prospective study. Lancet. 1996;348:145-149.
23. Chesnut CH III, Silverman S, Andriano K, 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;109:267-276.
24. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA. 1999;282:637-645.
25. Delmas PD, Ensrud KE, Adachi JD, 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;87:3609-3617.
26. 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;282:1344-1352.
27. Reginster J, 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.
28. 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;348:1535-1541.
29. 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;280:2077-2082.
30. Cummings SR, Karpf DB, Harris F, et al. Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med. 2002;112:281-289.
31. 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;17:1-10.
32. Watts NB, Cooper C, Lindsay R, et al. Relationship between changes in bone mineral density and vertebral fracture risk associated with risedronate: greater increases in bone mineral density do not relate to greater decreases in fracture risk. J Clin Densitom. 2004;7:255-261.
33. Solomon E. The roles of bone mineral density, bone turnover, and other properties in reducing fracture risk during antiresorptive therapy. Mayo Clin Proc. 2005;80:379-388.
34. Hajcsar EE, Hawker G, Bogoch ER. Investigation and treatment of osteoporosis in patients with fragility fractures. CMAJ. 2000;163:819-822.
35. Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997;337:670-676.
36. National Institutes of Health. Health Topics. Osteoporosis Overview. Available at: http://www.niams.nih.gov/bone/hi/overview.htm. Accessed February 23, 2006.
37. Rodan GA, Fleisch HA. Bisphosphonates: mechanisms of action. J Clin Invest. 1996;97:2692-2696.
38. Bone HG, Hosking D, Devogelaer JP, et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med. 2004;350:1189-1199.
39. Sorensen OH, Crawford GM, Mulder H, et al. Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone. 2003;32:120-126.
40. Roux C, Seeman E, Eastell R, et al. Efficacy of risedronate on clinical vertebral fractures within six months. Curr Med Res Opin. 2004;20:433-439.
41. Harrington JT, Ste-Marie LG, Brandi ML, et al. Risedronate rapidly reduces the risk for nonvertebral fractures in women with postmenopausal osteoporosis. Calcif Tissue Int. 2004;74:129-135.
42. McClung MR, Geusens P, Miller PD, et al; Hip Intervention Program Study Group. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med. 2001;344:333-340.
43. Seeman E, et al. Rapid and sustained effect of risedronate in reducing hip fracture risk in elderly women with osteoporosis. J Bone Miner Res. 2000; 15(suppl 1):S149, Abstract 1042.
44. Chesnut CH III, 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;19:1241-1249.
45. 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;20:1315-1322.
46. Miacalcin [package insert]. East Hanover, NJ:Novartis Pharmaceuticals Corp; 2003.
47. Munoz-Torres M, Alonso G, Raya MP. Calcitonin therapy in osteoporosis. Treat Endocrinol. 2004;3:117-132.
48. Cranney A, Adachi JD. Benefit-risk assessment of raloxifene in postmenopausal osteoporosis. Drug Saf. 2005;28:721-730.
49. Forteo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2002.
50. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344:1434-1441.
51. Anderson GL, Limacher M, Assaf AR, et al; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004;291:1701-1712.