Osteoporosis Self-assessment Tool (OST) [& OSTA for Asians]

1. Osteoporosis Self-assessment Tool (OST)[& OSTA for Asians] A simple clinical tool to identify women with osteoporosis Professor J-Y Reginster

2. Background • Cost and availability limit access to bone mineral density (BMD) in some communities • A simple risk assessment tool could: • target BMD to high-risk women • reduce the need for BMD measurements

3. Osteoporosis Self-assessment Tool for Asians (OSTA) Adapted from: L. Koh, et al. A simple tool to identify Asian women at increased risk of osteoporosis. Osteoporos Int 12:699-705, 2001.

4. Objective • Develop and assess a simple tool for predicting osteoporosis (femoral neck BMD T < -2.5) in postmenopausal Asian women, using risk factors obtained by questionnaire

5. Investigators The Osteoporosis Self-assessment Tool for Asia (OSTA) Research Group China : Huang Qi Ren, Zhang Wei Bin, Huang Gong Yi, Lou Si Quan, Luo Xian Zheng, Liu Gui Lin South Korea : In-Kwon Han, Ki-Hyun Park, Moo-Il Kang, Hyong-Moo Park, Hyoung-Woo Lee Taiwan : Chun S Shih, Li H Chen, Keh-Sung Tsai, Yang Bor-Yau Hong Kong : Annie Kung Philippines : Tito P Torralba Thailand : Rajata Rajatanavin Malaysia : Siew-Pheng Chan Singapore : Siok Bee Chionh, Tang Ching Lau, Paul Ho, Leonard Koh Belgium (WHO) : Jean-Yves Reginster, Wafa Ben Sedrine Japan (validation sample) : Saeko Fujiwara USA (MSD) : Philip Ross, Larry Radican

6. Method • Community-dwelling postmenopausal women • 21 clinics in 8 Asian countries • Consecutive subjects • Routine check-up or follow-up of medical conditions • 860 subjects completed questionnaires • Study was performed under the auspices of the World Health Organization (WHO)

7. Inclusion Postmenopausal Any race except Caucasian Hip anatomy suitable for BMD Willingness and ability to participate Exclusion History/evidence of metabolic bone disease Presence of cancer with known metastasis to bone Evidence of significant renal impairment One or both ovaries removed Both hips previously fractured or replaced History of bisphosphonate, fluoride or calcitonin use Recruitment Criteria

8. Ethnicity Weight Height (present/past) Physical activity Sunlight exposure Smoking Dairy / soybean intake Reproductive history Physical disability Rheumatoid arthritis Fracture history Family history of fracture Calcium supplements Postmenopausal estrogen Thyroid medication Corticosteroids Risk Factors Assessed in Questionnaire

9. Results: Study Population • Demographics Chinese: 59% Korean: 18% Thai: 11% Filipino: 9% Other: 4% • Age (years) 62 (6) • Weight (kg) 57 (9) • Height (cm) 154 (6) • Femoral neck BMD (g/cm2) 0.71 (0.14) • 14% of women had T-scores < -2.5

10. Multivariate Analysis • Multivariable model - “best fit” • 11 variables: • age • weight • estrogen • thyroid medication • any fracture since 45 • prior spine fracture • Chinese • Thai • 3 countries (Malaysia, Hong Kong, Taiwan)

11. Simple Model (2 variables)Performs Well Koh L, et al. Osteoporos Int 12:699-705, 2001.

12. Calculation Model with only 2 variables (Weight - Age) x 0.2, drop decimal example: Weight 59 kg, Age 72 yr (59-72) x 0.2 = -2 Koh L, et al. Osteoporos Int 12:699-705, 2001.

13. % of all women 40% 52% 8% % with osteoporosis 3% 15% 61% Risk level Low Medium High Risk Stratification Koh L, et al. Osteoporos Int 12:699-705, 2001.

14. Validation - JAPAN • Adult Health Study, Hiroshima • Postmenopausal women in existing cohort • Ages 50 and older • N = 1123 • Sensitivity = 98%, specificity = 29% Fujiwara S, et al. Curr Ther Res 62(8): 586-94, 2001.

15. % with osteo-porosis 1% 10% 44% % with osteo-porosis 3% 15% 61% % of all women 25% 50% 25% % of all women 40% 52% 8% Development (Asian) Validation (Japan) Risk level Low Medium High Fujiwara S, et al. Curr Ther Res 62(8): 586-94, 2001.

16. 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95-99 Osteoporosis Self-assessment Tool for Asia (OSTA) Weight (kg) LOW RISK Age (yr) AT RISK measure BMD HIGH RISK measure BMD & treat History of prior non-violent fracture: consider BMD measurement and treatment

17. Validation - KOREA • Postmenopausal women • Ages > 55 • N = 1101 • Sensitivity = 87%, specificity = 67% Ben Sedrine W, et al. Arth Rheum 44(9 Suppl):S260, 2001.

18. % with osteo-porosis 2% 18% 64% % with osteo-porosis 3% 15% 61% % of all women 61% 33% 5% % of all women 40% 52% 8% Development (Asian) Validation (KOREA) Risk level Low Medium High Fujiwara S, et al. Curr Ther Res 62(8): 586-94, 2001.

19. Validation - SINGAPORE • 125 Postmenopausal women • Mean 60 ± 7.5 yr (range 50 - 89 yr) • Sensitivity = 94%, specificity = 64% • AUC = 0.83 • 98 Men • Mean 61 ± 8.8 yr (range 50 - 88 yr) • Sensitivity = 50%, specificity = 78% • AUC = 0.71 Koh L, et al. J Bone Miner Res 16(Suppl 1):S394 & S396, 2001.

20. % with osteo-porosis 2% 24% 80% % with osteo-porosis 13% 26% 75% % of all women 53% 43% 4% % of all men 72% 24% 4% RESULTS - SINGAPORE WOMEN MEN Risk level Low Medium High Koh L, et al. J Bone Miner Res 16(Suppl 1):S394 & S396, 2001.

21. % with osteo-porosis 13% 26% 75% % of all men 72% 24% 4% Validation (SINGAPORE) Risk level Low Medium High Koh L, et al. J Bone Miner Res 16(Suppl 1):S394 & S396, 2001.

22. Validation - CHINA • 973 Postmenopausal women • Clinic in Shanghai • 91 women (9%) had osteoporosis • 557 (57%) had osteopenia • Sensitivity = 92%, specificity = 54% • AUC = 0.84 Ben Sedrine W, et al. Arth Rheum 44(9 Suppl):S258, 2001.

23. % with osteo-porosis 1% 13% 42% % with osteo-porosis 3% 15% 61% % of all women 50% 43% 7% % of all women 40% 52% 8% Development (Asian) Validation (China) Risk level Low Medium High Ben Sedrine W, et al. Arth Rheum 44(9 Suppl):S258, 2001.

24. Summary - OSTA • Age and weight alone performed well for identifying osteoporosis • Consistent results among countries • Including more variables did not substantially improve performance • Using 3 categories may help to identify the highest and lowest risk groups • BMD measurements are probably unnecessary in a substantial proportion of low risk women

25. Osteoporosis Self-assessment Tool (OST) Performance in Caucasians

26. Validation - Caucasians • Original “SCORE” population • Postmenopausal women in the US • Ages > 45 (mean = 61 yr) • N = 1102 • Sensitivity = 88%, specificity = 52% • Adding other risk factors did not improve performance Siris et al, J Bone Miner Res 16(Suppl 1):S341, 2001.

27. Validation - Caucasians • Screening for Fracture Intervention Trial • Postmenopausal women in the US • Mean age 68 yr (SD = 6) • N = 23,833 • Sensitivity = 95%, specificity = 34% • Adding other risk factors did not improve performance Hochberg et al, J Bone Miner Res 16(Suppl 1):S277, 2001.

28. % with osteo-porosis 4% 18% 58% % with osteo-porosis 4% 23% 57% % of all women 46% 48% 6% % of all women 24% 67% 8% FIT screen population SCORE population Risk level Low (>1) Medium High (<-3) Hochberg et al, J Bone Miner Res 16(Suppl 1):S277, 2001. Siris et al, J Bone Miner Res 16(Suppl 1):S341, 2001.

29. 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95-99 >99 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95-99 Osteoporosis Self-assessment Tool (OST) Weight (kg) LOW RISK Age (yr) AT RISK measure BMD HIGH RISK measure BMD & treat History of prior non-violent fracture: consider BMD measurement and treatment

30. OST - CaucasiansSimple Rules *Age in yr minus weight in kg

31. SUMMARY • Both OST and OSTA performed well • Consistent results in different samples • Using 3 categories may help to identify the highest and lowest risk groups • BMD measurements are probably unnecessary in a substantial proportion of low risk women • Category cut-points were slightly different in Caucasian versus Asian women