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Understanding Osteoporosis
 

Understanding Osteoporosis

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  • 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

Understanding Osteoporosis Understanding Osteoporosis Presentation Transcript

  • Osteoporosis -a Silent disease Dr. Kevin M. H. Yip Singapore Orthopaedic Surgeon Gleneagles Medical Centre
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  • Definition
    • is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture
  • Risk Factors
    • Age and Sex
    • A previous non-violent fracture
    • Early menopause
    • Family Hx
    • Being underweight
    • Smoking/ alcohol/ lack exercise/diet/
    • Steriods
  • Local Data
    • A study in 1991-
    • 800 Singaporean women over the age of 50 suffered hip fractures per year
    • 20% died within one year
    • Over half of those who survived became dependent on their family
    • The medical cost was over 5.6 million dollars a year.
  • 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
  • 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)
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  • Diagnosis
    • Non-invasive test for measurement of BMD
    • Major technologies
      • Dual-energy X-ray Absorptiometry (DXA)
      • Quantitative Ultrasound (QUS)
      • Quantitative Computerized Tomography (QCT)
    • Many manufacturers
    • Numerous devices
    • Different skeletal sites
  • Diagnosis of Osteoporosis
    • The presence of a fragility fracture or
    • A bone mineral density (BMD) measurement which falls below a threshold level set at 2.5 S.D below the mean peak bone mass of young adults
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  • 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
    • Pain
    • Physical deformity
    • disability, loss of independence and death.
  • Treatment
    • High calcium intake ( 1500mg per day)
    • Regular weight-bearing exercise
    • Stop smoking and avoid excessive alcohol and coffee consumption
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    • Calcium and Vitamin D
    • Hormone Replacement Therapy (HRT)
    • Selective Estrogen Receptor Modulators (SERMS)- countering the effect of reduced estrogen levels, side effects include hot flushes
    • Bisphosphonates- side effects include oesophagitis
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  • Ten Years’ Experience with Alendronate for Osteoporosis in Postmenopausal Women.
    • N Engl J Med 2004;350:1189-99.
    • The 10 year results were first presented at 3 rd International Symposium on the Clinical and Economic Aspects of Osteoporosis, November 2002, Spain.
    • The results extend the previous longest available safety and efficacy data of alendronate from 7 years to 10 years.
    • These data represent the longest safety and efficacy data available for a non-hormonal osteoporosis therapy.
  • 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
  • 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
  • Alendronate 10 Years Data: Conclusions for Alendronate 10mg
    • At 10 years, 13.8% increase in lumbar spine BMD vs baseline
    • At 10 years, 6.8% increase in total hip BMD vs baseline
    • Stable reduction of bone turnover to premenopausal levels (normal range)
    • Non-vertebral fracture incidence similar in Years 8-10 vs Years 1-3
    Bone HG et al. Ten Years’ Experience with Alendronate for Osteoporosis in Postmenopausal Women. N Engl J Med 2004;350:1189-99
  • Current Knowledge of Alendronate and Raloxifene
    • Both alendronate and raloxifene are used for postmenopausal osteoporosis
    • Meta-analyses of clinical data for each agent have recently been performed [Cranney A et al Endocr Rev 2002;23(4):570-578]
    • No head-to-head fracture trial data currently available
      • Requires large patient population (tens of thousands)
      • Long duration (>3 years)
    • One study assessed the individual and additive effects of alendronate and raloxifene [Johnell O et al J Clin Endocrinol Metab 2002;87(3):985-992]
    • EFFECT was conducted to provide head-to-head data for alendronate once weekly vs. raloxifene in postmenopausal osteoporosis
    RCT=randomized clinical trial Adapted from Cranney A et al Endocr Rev 2002;23(4):570-578; Cranney A et al Endocr Rev 2000;23(4):496-507; Johnell O et al J Clin Endocrinol Metab 2002;87(3):985-992; Sambrook P et al. Poster presented at the 2003 International Bone and Mineral Society meeting, Osaka, Japan, June 2–7, 2003.
  • Alendronate vs. Raloxifene: Overall Summary
    • Large-scale, head-to-head BMD trials can provide clinicians with useful information
    • EFFECT–International demonstrated
      • Alendronate 2–3 times more effective than raloxifene once daily for increasing lumbar spine and hip BMD
      • Similar tolerability
    • Results from EFFECT–International consistent with independent meta-analyses
      • Alendronate outperformed raloxifene in increasing BMD
      • In the ORAG meta-analysis, alendronate also outperformed raloxifene in lowering risk of both vertebral and nonvertebral fractures
    Adapted from Sambrook P et al. Poster presented at the 2003 International Bone and Mineral Society meeting, Osaka, Japan, June 2–7, 2003; Cranney A et al Endocr Rev 2002;23(4):570-578.
  • Summary
    • Osteoporosis is significant health problem
    • With high mobility and motility
    • Mx begins prevention,
    • Diagnosis-BMD
    • Treatment-lifestyle, medication
    • Some medicine more effective than others
    • Thank You
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