Understanding Osteoporosis
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Understanding Osteoporosis
- 1. Osteoporosis -a Silent disease Dr. Kevin M. H. Yip Singapore Orthopaedic Surgeon Gleneagles Medical Centre
- 6. 3-Fold Increase In Population Over 65 Years Old… 19% 6% Source: Ministry of Health Osteoporosis Guidelines 2/2002 3x Osteoporosis Is an Increasingly Important Health Issue in Singapore
- 7. Source: Wong MK et al . Osteoporotic Hip Fractures in Singapore – Cost’s and Patient’s Outcome. Ann Acad Med Singapore 2002; 31:3-7 Osteoporotic Fractures Are Associated With Mortality and Morbidity For every 4 hip fracture patients in Singapore: Osteoporosis Is an Increasingly Important Health Issue in Singapore 1 do not survive 1 become bedridden or wheelchair-bound 2 can continue walking (mostly with aids)
- 27. Fracture Rates by T-score at 1-Year Follow-Up Adapted from Siris ES et al. Bone Mineral Density Thresholds for Pharmacological Intervention to Prevent Fractures. Arch Intern Med 2004; 164:1108-1112 Fracture Rate 50 5 15 20 25 30 40 45 35 10 0 < 3.5 Fracture Rate Per 1,000 Person-Years 2.5 to 3.0 2.0 to 2.5 1.5 to 2.0 1.0 to 1.5 0.5 to 1.0 0.0 to 0.5 0.5 to 0.0 1.0 to 0.5 > 1.0 BMD 3.0 to 3.5 T-score BMD Distribution 450 400 350 300 250 200 150 100 50 0 Absolute # Fractures NORA
- 34. Alendronate 10 Years Data: Lumbar Spine BMD Continuous Increase Through 10 Years 13.8% vs baseline Bone HG et al. Ten Years’ Experience with Alendronate for Osteoporosis in Postmenopausal Women. N Engl J Med 2004;350:1189-99 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 0 12 24 36 48 60 72 84 96 108 120 Mean Percent Change Month ALN 5 mg ALN 10 mg ALN 20 mg/ALN 5 mg/Placebo
- 35. Alendronate 10 Years Data: Total Hip BMD Maintained in Years 8 - 10 6.8% vs baseline Bone HG et al. Ten Years’ Experience with Alendronate for Osteoporosis in Postmenopausal Women. N Engl J Med 2004;350:1189-99 0 1 2 3 4 5 6 7 8 9 0 12 24 36 48 60 72 84 96 108 120 Mean Percent Change Month ALN 5 mg ALN 10 mg ALN 20 mg/ALN 5 mg/Placebo
Editor's Notes
- Fracture Rates by T-score During 1-Year Follow-Up The fracture rate analysis was performed on data from the cohort of postmenopausal Caucasian women. A total of 2,259 fractures was reported at the 1-year follow-up: 393 hip, 658 rib, 277 spine, and 1,012 wrist/forearm fractures. Low BMD T-scores are associated with higher fracture rates compared with normal BMD measurements. Distribution of BMD T- scores were approximates a normal distribution. Absolute number of fractures were the highest in the group with T-score range of -1.5 to -2.0 Fracture rate is reported as the no of women who fractured per 1,000 person-years. 2 To articulate that; 82% of the women who reported fractures at 1 year had T-score greater than -2.5
- Currently, the bisphosphonate alendronate and the selective estrogen receptor modulator raloxifene are used for postmenopausal osteoporosis. Recent meta-analyses by Cranney et al evaluated clinical data for these agents to aid practicing clinicians in managing osteoporosis. 1,2 Such analyses can provide objective, comprehensive summaries of available data. Statistically significant anti-fracture differences between two active treatments can only be detected in specially designed fracture endpoint studies. These studies require large patient populations, potentially tens of thousands of patients, and evaluations over long durations of at least three years of treatment. 3 However, changes in BMD and bone turnover have been shown to be highly predictive of the anti-fracture efficacy of osteoporosis therapies 4,5 and can provide clinically relevant information about the relative efficacies of these therapies. 4 This information can be valuable to physicians in selecting a therapy that provides the greatest improvements in BMD or bone turnover and accordingly the best reduction in fracture risk. 4 To date, only one published RCT has provided data on the clinical response of post-menopausal women to alendronate 10 mg once daily or raloxifene 60 mg once daily. 6 The purpose of the study was to assess the additive effects of alendronate and raloxifene. Two large, similarly designed RCTs, the EF ficacy of Fosamax® vs. E vista ® C omparison T rial, known as EFFECT–US and EFFECT–International, were conducted to provide additional head-to-head data for alendronate versus raloxifene in postmenopausal osteoporosis. 7 References Cranney A, Guyatt G, Griffith L et al. IX. Summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 2002;23(4):570-578. Cranney A, Tugwell P, Wells G et al. I. Systematic reviews of randomized trials in osteoporosis: Introduction and methodology. Endocr Rev 2000;23(4):496-507. Kanis JA, Oden A, Johnell O et al. Uncertain future of trials in osteoporosis. Osteoporos Int 2002;13:443-449. Hochberg MC, Greenspan S, Wasnich RD et al. Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents. J Clin Endocrinol 2002;87:1586-1592. Looker AC, Bauer DC, Chesnut CH III et al. Clinical use of biochemical markers of bone remodeling: Current status and future directions. Osteoporos Int 2000;11:467-480. Johnell O, Scheele WH, Lu Y et al. 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):985-992. Sambrook P, Geusens P, Keraudren V et al. Efficacy of Fosamax vs. Evista Comparison Trial (EFFECT–International): Results at 6 and 12 months. Poster presented at the 2003 International Bone and Mineral Society meeting, Osaka, Japan, June 2–7, 2003. Slide
- Large-scale, head-to-head comparative trials provide useful information about the relative efficacy, safety, and tolerability of pharmacotherapies. EFFECT–International demonstrated that alendronate was two to three times more effective than raloxifene for increasing lumbar spine and hip BMD, with a similar tolerability profile. 1 The results of EFFECT–International are supported by similar findings in the similarly designed EFFECT trial conducted in the US. 2 These results are consistent with those of an independent meta-analysis of data for alendronate and raloxifene from other RCTs. In this meta-analysis, alendronate outperformed raloxifene by increasing BMD at key body sites. 3 In the ORAG meta-analysis, alendronate also outperformed raloxifene in lowering the risk of both vertebral and nonvertebral fractures. 3 References Sambrook P, Geusens P, Keraudren V et al. Efficacy of Fosamax vs. Evista Comparison Trial (EFFECT–International): Results at 6 and 12 months. Poster presented at the 2003 International Bone and Mineral Society meeting, Osaka, Japan, June 2–7, 2003. Bone H, Greenspan SL, Miller P et al. Ef ficacy of Fosamax® vs. E vista ® C omparison T rial (EFFECT): Results of a randomized, multicenter study. Poster presented at the 2003 International Bone and Mineral Society meeting, Osaka, Japan, June 2–7, 2003. Cranney A, Guyatt G, Griffith L et al. IX. Summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 2002;23(4):570-578. Slide