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Cost Effective Treatment of Osteoporosis Utilizing the US Adapted WHO Fracture Risk Algorithm  Sanford Baim MD, FACR, CCD Colorado Center for Bone Research Lakewood, Colorado
Discussion Points ,[object Object],[object Object],[object Object],[object Object]
WHO Bone Density Criteria: A Diagnostic Threshold Diagnostic criteria* Classification T is above or equal to -1  Normal T is between -1 and -2.5 Osteopenia (low bone mass) T -2.5 or lower Osteoporosis T -2.5 or lower + fragility fracture Severe established osteoporosis * T-score is the number of standard deviations above or below the average peak bone density in young adults
Treatment Guidelines Prior to 2008 Based on BMD and CRFs T-score thresholds Treat Do not Treat BMD + CRFs NOF   NOF Risk Factors AACE Risk Factors NAMS Risk Factors ACOG Risk Factors ALL Fragility Fracture (with or without low BMD) -2.5 -2.0 -1.5
Clinical Utility of the WHO T-score Diagnostic Classification ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Caveats of the WHO T-score  Diagnostic Classification ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BMD and Relative Risk Bone Density (T-score) Relative Risk  for Fracture Marshall,  BMJ,  1996
Gradients of Risk in Women for a 1 SD Decrease in BMD Below Age-adjusted mean Site of  Measurement Distal radius Hip Lumbar spine Forearm Fracture 1.7   1.4  1.5  Hip Fracture 1.8  2.6 1.6   Vertebral Fracture 1.7  1.8  2.3  All Fractures 1.4   1.6   1.5   Marshall,  BMJ,  1996
Example of Relative Risk Using T-scores in Fracture Prediction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],C ,[object Object]
Relative Risk Using T-scores and GR  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Absolute Risk Using FRAX ™ ,[object Object],[object Object]
Problem with Relative Risk and Fracture Prediction ,[object Object],[object Object],[object Object],[object Object]
Problem with Fracture Prediction Using T-scores and  WHO Diagnostic Criteria
C Number of subjects BMD in Patients  With and Without Fractures  EPOS Study Group,  JBMR , 2002
Relationship Between Fracture Risk & BMD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Kanis,  OI , 2008
Effect of Gradient of Risk on Prediction of Future Fracture Risk
Age as an Independent Risk Factor  for Fracture Adapted from Kanis ,  OI , 2001 Probability of clinical osteoporotic fractures in Swedish women Gradient of risk  Ten Year Fracture Probability (%)  Age 80 70 60 50
Prior Fracture as an Independent Risk Factor for Fracture Klotzbuecher ,  JBMR , 2000 RR Incident Fracture Prevalent Fracture Wrist Vertebra Hip Wrist 3.3 1.7 1.9 Vertebra 1.4 4.4 2.3 Hip NA 2.5 2.3
Combined Effect of BMD and Clinical Risk Factors on Fracture Risk Rate of hip fracture (per 1000 woman-yr) Calcaneal bone density No. of  risk  factors Cummings,  N EJM,  1995 27.3 14.7 9.4 0 5 10 15 20 25 30 Lowest third Middle third Highest third 0-2 3-4 >4
Fracture Probability
WHO Scientific Group on Assessment  of Osteoporosis at the Primary Health Care Level ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],WHO Scientific Group on the Assessment of  Osteoporosis At the Primary Health Care Level, 2008 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],WHO Assessment of Fracture Probability Project WHO Scientific Group on the Assessment of  Osteoporosis At the Primary Health Care Level, 2008
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],WHO Assessment of Fracture Probability Project WHO Scientific Group on the Assessment of  Osteoporosis At the Primary Health Care Level, 2008
WHO Fracture Risk Model -FRAX™- ,[object Object],[object Object],[object Object],[object Object],[object Object],WHO Scientific Group on the Assessment of  Osteoporosis At the Primary Health Care Level, 2008
FRAX ™ Model Analysis of CRFs ,[object Object],[object Object],[object Object],[object Object],[object Object]
FRAX™ Clinical Risk Factors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
Secondary Etiologies Associated  With Increased Fracture Risk ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],WHO Scientific Group on the Assessment of Osteoporosis At the Primary Health Care Level, 2008
FRAX 10-year Fracture Risk  Using the Same Demographics Except for Race/Ethnicity ,[object Object],[object Object],[object Object],[object Object],[object Object]
FRAX Beta-Site http://www.shef.ac.uk/FRAX/tool
FRAX Beta-Site http://www.shef.ac.uk/FRAX/tool
FRAX – USA (Caucasian Female) http://www.shef.ac.uk/FRAX/tool
FRAX USA – (Hispanic female) http://www.shef.ac.uk/FRAX/tool
FRAX USA – (Asian female) http://www.shef.ac.uk/FRAX/tool
FRAX – USA (Black female) http://www.shef.ac.uk/FRAX/tool
Secondary osteoporosis / No BMD Secondary osteoporosis + BMD Secondary osteoporosis/No BMD+RA BMD without secondary CRFs  ☻ ☻ ☻ ☻
Low BMI / No BMD Normal BMI / No BMD Normal BMI + BMD Low BMI + BMD
FRAX™ Caveats  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],FRAX™ Caveats
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],FRAX™ Caveats
FRAX Patch http://www.orost.com/fraxpatch
[object Object],[object Object],[object Object],[object Object],FRAX ™  Patch: Background Courtesy of Mike McClung
[object Object],[object Object],[object Object],[object Object],FRAX ™  Patch: Background Courtesy of Mike McClung
FRAX ™   Patch ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Courtesy of Mike McClung
Summary Courtesy of Mike McClung www.orost.com/fraxpatch
Courtesy of Mike McClung www.orost.com/fraxpatch
Use of FRAX™ on DXA Machines ,[object Object],[object Object],[object Object],[object Object]
Integrated FRAX Report ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
NOF Clinician’s Guide To Prevention and Treatment of Osteoporosis Development Committee  Bess Dawson-Hughes (Chair), NOF Robert Lindsay (Co-chair), NOF Sundeep Khosla, NOF L. Joseph Melton III, NOF Anna N.A. Tosteson, NOF Murray Favus, ASBMR Sanford Baim, ISCD  Interspecialty Medical Council Reviewers   Laura Tosi, AAOS  Kenneth W. Lysles, AGS   Martin Grabois, AAP  Helena W. Rodbard, AMA   Richard W. Kruse, AAP  Marc F. Swiontkowski, AOA    Partricia Graham, AAPMR  Kendrin Van Steenwyk, AOA   Donald Berman, AACE  Shonni Silverberg, ASBMR   William C. Andrews, ACOG  E. Michael Lewiecki, ISCD   Michael Gloth III, ACP  John L. Melvin, ISPRM   Ronald Bernard Staron, ACR  Wendi El-Amin, NMA   Lenore Buckley, ACRheum  Carolyn Becker, TES
NOF Clinician’s Guide To Prevention and Treatment of Osteoporosis  –Contents–   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.nof.org/professionals/Clinicians_Guide.htm
NOF Technical Reports ,[object Object],[object Object],[object Object],[object Object],[object Object],Tosteson,  OI , 2008
NOF Technical Reports ,[object Object],[object Object],[object Object],[object Object],[object Object],Dawson-Hughes,  OI , 2008
Determination of US Cost-Effective Treatment Threshold ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Borgstrom ,  OI, 2 006
NOF Methodology and Assumptions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],*Clinical Fractures: hip, wrist, spine and “other”  including proximal humerus, rib, pelvis, & tibia/fibula ( ♀  only) Tosteson,  OI , 2008
NOF Methodology and Assumptions ,[object Object],[object Object],[object Object],[object Object],[object Object],Tosteson,  OI , 2008
NOF Methodology and Assumptions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Tosteson,  OI , 2008
[object Object],NOF Methodology and Assumptions Tosteson,  OI,  2008
NOF Methodology and Assumptions ,[object Object],Tosteson,  OI , 2008  Parameter Hip Fracture Disutility in 1 st  year 0.208 Disutility in 2 nd  year 0.187 Cost in 1 st  year $29,449 Cost-subsequent years $7,156
Impact of Duration in Fracture-Loss in Quality of Life on 10-year Hip Fracture Which Treatment Becomes Cost-effective Tosteson,  OI , 2008
NOF Methodology and Assumptions ,[object Object],[object Object],[object Object],[object Object],[object Object],Tosteson,  OI , 2008
NOF 2008 Treatment  Recommendations ,[object Object],[object Object],[object Object],[object Object],[object Object],www.nof.org/professionals/Clinicians_Guide.htm
10-year Fracture Risk  50 Year Old White Female with BMI 24  5.2% 0.4% 9.4% 2.5% 2.5% 9.2% 16% 2.6% 10% 4.3% 17% 4.5% 28% 8.3%
2003 NOF Physician Guide  Treatment Recommendations Core data from Kanis,  OI , 2001 McClung,  Bone , 2005
2008 NOF Clinician Guide  Treatment Recommendations Core data from Kanis ,  OI,  2001 McClung,  Bone,  2005 NOF Clinician Guide, 2008, www.NOF.org
Summary and Implications of NOF  Cost-effective Intervention Threshold ,[object Object],[object Object],[object Object],[object Object],www.nof.org/professionals/Clinicians_Guide.htm
Summary and Implications of NOF  Cost-effective Intervention Threshold ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.nof.org/professionals/Clinicians_Guide.htm
2008 NOF Guide ,[object Object],[object Object],www.nof.org/professionals/Clinicians_Guide.htm
Caveats of the NOF Therapeutic Guidelines ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Gestalt Psychology of Clinical Decisions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Cost-effective Treatment and Fracture Risk

  • 1. Cost Effective Treatment of Osteoporosis Utilizing the US Adapted WHO Fracture Risk Algorithm Sanford Baim MD, FACR, CCD Colorado Center for Bone Research Lakewood, Colorado
  • 2.
  • 3. WHO Bone Density Criteria: A Diagnostic Threshold Diagnostic criteria* Classification T is above or equal to -1 Normal T is between -1 and -2.5 Osteopenia (low bone mass) T -2.5 or lower Osteoporosis T -2.5 or lower + fragility fracture Severe established osteoporosis * T-score is the number of standard deviations above or below the average peak bone density in young adults
  • 4. Treatment Guidelines Prior to 2008 Based on BMD and CRFs T-score thresholds Treat Do not Treat BMD + CRFs NOF NOF Risk Factors AACE Risk Factors NAMS Risk Factors ACOG Risk Factors ALL Fragility Fracture (with or without low BMD) -2.5 -2.0 -1.5
  • 5.
  • 6.
  • 7. BMD and Relative Risk Bone Density (T-score) Relative Risk for Fracture Marshall, BMJ, 1996
  • 8. Gradients of Risk in Women for a 1 SD Decrease in BMD Below Age-adjusted mean Site of Measurement Distal radius Hip Lumbar spine Forearm Fracture 1.7 1.4 1.5 Hip Fracture 1.8 2.6 1.6 Vertebral Fracture 1.7 1.8 2.3 All Fractures 1.4 1.6 1.5 Marshall, BMJ, 1996
  • 9.
  • 10.
  • 11.
  • 12. Problem with Fracture Prediction Using T-scores and WHO Diagnostic Criteria
  • 13. C Number of subjects BMD in Patients With and Without Fractures EPOS Study Group, JBMR , 2002
  • 14.
  • 15. Effect of Gradient of Risk on Prediction of Future Fracture Risk
  • 16. Age as an Independent Risk Factor for Fracture Adapted from Kanis , OI , 2001 Probability of clinical osteoporotic fractures in Swedish women Gradient of risk Ten Year Fracture Probability (%) Age 80 70 60 50
  • 17. Prior Fracture as an Independent Risk Factor for Fracture Klotzbuecher , JBMR , 2000 RR Incident Fracture Prevalent Fracture Wrist Vertebra Hip Wrist 3.3 1.7 1.9 Vertebra 1.4 4.4 2.3 Hip NA 2.5 2.3
  • 18. Combined Effect of BMD and Clinical Risk Factors on Fracture Risk Rate of hip fracture (per 1000 woman-yr) Calcaneal bone density No. of risk factors Cummings, N EJM, 1995 27.3 14.7 9.4 0 5 10 15 20 25 30 Lowest third Middle third Highest third 0-2 3-4 >4
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 30. FRAX – USA (Caucasian Female) http://www.shef.ac.uk/FRAX/tool
  • 31. FRAX USA – (Hispanic female) http://www.shef.ac.uk/FRAX/tool
  • 32. FRAX USA – (Asian female) http://www.shef.ac.uk/FRAX/tool
  • 33. FRAX – USA (Black female) http://www.shef.ac.uk/FRAX/tool
  • 34. Secondary osteoporosis / No BMD Secondary osteoporosis + BMD Secondary osteoporosis/No BMD+RA BMD without secondary CRFs ☻ ☻ ☻ ☻
  • 35. Low BMI / No BMD Normal BMI / No BMD Normal BMI + BMD Low BMI + BMD
  • 36.
  • 37.
  • 38.
  • 40.
  • 41.
  • 42.
  • 43. Summary Courtesy of Mike McClung www.orost.com/fraxpatch
  • 44. Courtesy of Mike McClung www.orost.com/fraxpatch
  • 45.
  • 46.
  • 47.  
  • 48.  
  • 49. NOF Clinician’s Guide To Prevention and Treatment of Osteoporosis Development Committee Bess Dawson-Hughes (Chair), NOF Robert Lindsay (Co-chair), NOF Sundeep Khosla, NOF L. Joseph Melton III, NOF Anna N.A. Tosteson, NOF Murray Favus, ASBMR Sanford Baim, ISCD Interspecialty Medical Council Reviewers Laura Tosi, AAOS Kenneth W. Lysles, AGS Martin Grabois, AAP Helena W. Rodbard, AMA Richard W. Kruse, AAP Marc F. Swiontkowski, AOA Partricia Graham, AAPMR Kendrin Van Steenwyk, AOA Donald Berman, AACE Shonni Silverberg, ASBMR William C. Andrews, ACOG E. Michael Lewiecki, ISCD Michael Gloth III, ACP John L. Melvin, ISPRM Ronald Bernard Staron, ACR Wendi El-Amin, NMA Lenore Buckley, ACRheum Carolyn Becker, TES
  • 50.
  • 51.
  • 52.
  • 53.
  • 54.
  • 55.
  • 56.
  • 57.
  • 58.
  • 59. Impact of Duration in Fracture-Loss in Quality of Life on 10-year Hip Fracture Which Treatment Becomes Cost-effective Tosteson, OI , 2008
  • 60.
  • 61.
  • 62. 10-year Fracture Risk 50 Year Old White Female with BMI 24 5.2% 0.4% 9.4% 2.5% 2.5% 9.2% 16% 2.6% 10% 4.3% 17% 4.5% 28% 8.3%
  • 63. 2003 NOF Physician Guide Treatment Recommendations Core data from Kanis, OI , 2001 McClung, Bone , 2005
  • 64. 2008 NOF Clinician Guide Treatment Recommendations Core data from Kanis , OI, 2001 McClung, Bone, 2005 NOF Clinician Guide, 2008, www.NOF.org
  • 65.
  • 66.
  • 67.
  • 68.
  • 69.