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

Downloaded from www. fosavance. ae Background • Cost and availability limit access to bone Downloaded from www. fosavance. ae 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 2

Downloaded from www. fosavance. ae Osteoporosis Self-assessment Tool for Asians (OSTA) Adapted from: L. Downloaded from www. fosavance. ae 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. 3

Downloaded from www. fosavance. ae Objective • Develop and assess a simple tool for Downloaded from www. fosavance. ae 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 4

Downloaded from www. fosavance. ae Investigators The Osteoporosis Self-assessment Tool for Asia (OSTA) Research Downloaded from www. fosavance. ae 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 : 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 5

Downloaded from www. fosavance. ae Method • Community-dwelling postmenopausal women – 21 clinics in Downloaded from www. fosavance. ae 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) 6

Downloaded from www. fosavance. ae Recruitment Criteria • Inclusion – – Postmenopausal Any race Downloaded from www. fosavance. ae Recruitment Criteria • 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 bisphonate, fluoride or calcitonin use 7

Downloaded from www. fosavance. ae Risk Factors Assessed in Questionnaire • • Ethnicity Weight Downloaded from www. fosavance. ae Risk Factors Assessed in Questionnaire • • 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 8

Downloaded from www. fosavance. ae Results: Study Population • Demographics Chinese: 59% Filipino: 9% Downloaded from www. fosavance. ae Results: Study Population • Demographics Chinese: 59% Filipino: 9% Korean: 18% Other: 4% Thai: 11% • Age (years) 62 (6) • Weight (kg) 57 (9) • Height (cm) 154 (6) • Femoral neck BMD (g/cm 2) 0. 71 (0. 14) – 14% of women had T-scores < -2. 5 9

Downloaded from www. fosavance. ae Multivariate Analysis • Multivariable model - “best fit” – Downloaded from www. fosavance. ae 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) 10

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

Downloaded from www. fosavance. ae Calculation Model with only 2 variables (Weight - Age) Downloaded from www. fosavance. ae 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. 12

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

Downloaded from www. fosavance. ae Validation - JAPAN • Adult Health Study, Hiroshima – Downloaded from www. fosavance. ae 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. 14

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

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

Downloaded from www. fosavance. ae Validation - KOREA • Postmenopausal women – Ages > Downloaded from www. fosavance. ae Validation - KOREA • Postmenopausal women – Ages > 55 – N = 1101 • Sensitivity = 87%, specificity = 67% Ben Sedrine W, et al. Arth Rheum 44(9 Suppl): S 260, 2001. 17

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

Downloaded from www. fosavance. ae Validation - SINGAPORE • 125 Postmenopausal women – Mean Downloaded from www. fosavance. ae 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): S 394 & S 396, 2001. 19

Downloaded from www. fosavance. ae RESULTS - SINGAPORE MEN WOMEN % of all women Downloaded from www. fosavance. ae RESULTS - SINGAPORE MEN WOMEN % of all women % with osteoporosis % of all men % with osteoporosis Low 53% 2% 72% 13% Medium 43% 24% 26% High 4% 80% 4% 75% Risk level Koh L, et al. J Bone Miner Res 16(Suppl 1): S 394 & S 396, 2001. 20

Downloaded from www. fosavance. ae Validation (SINGAPORE) % of all men % with osteoporosis Downloaded from www. fosavance. ae Validation (SINGAPORE) % of all men % with osteoporosis Low 72% 13% Medium 24% 26% High 4% 75% Risk level Koh L, et al. J Bone Miner Res 16(Suppl 1): S 394 & S 396, 2001. 21

Downloaded from www. fosavance. ae Validation - CHINA • 973 Postmenopausal women – Clinic Downloaded from www. fosavance. ae 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): S 258, 2001. 22

Downloaded from www. fosavance. ae Validation (China) Development (Asian) % of all women % Downloaded from www. fosavance. ae Validation (China) Development (Asian) % of all women % with osteoporosis Low 50% 1% 40% 3% Medium 43% 13% 52% 15% High 7% 42% 8% 61% Risk level Ben Sedrine W, et al. Arth Rheum 44(9 Suppl): S 258, 2001. 23

Downloaded from www. fosavance. ae Summary - OSTA • Age and weight alone performed Downloaded from www. fosavance. ae 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 24

Downloaded from www. fosavance. ae Osteoporosis Self-assessment Tool (OST) Performance in Caucasians 25 Downloaded from www. fosavance. ae Osteoporosis Self-assessment Tool (OST) Performance in Caucasians 25

Downloaded from www. fosavance. ae Validation - Caucasians • Original “SCORE” population – Postmenopausal Downloaded from www. fosavance. ae 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): S 341, 2001. 26

Downloaded from www. fosavance. ae Validation - Caucasians • Screening for Fracture Intervention Trial Downloaded from www. fosavance. ae 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): S 277, 2001. 27

Downloaded from www. fosavance. ae SCORE population FIT screen population Risk level % of Downloaded from www. fosavance. ae SCORE population FIT screen population Risk level % of all women % with osteoporosis Low (>1) 46% 4% 24% 4% Medium 48% 18% 67% 23% High (<-3) 6% 58% 8% 57% Hochberg et al, J Bone Miner Res 16(Suppl 1): S 277, 2001. Siris et al, J Bone Miner Res 16(Suppl 1): S 341, 2001. 28

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

Downloaded from www. fosavance. ae OST - Caucasians Simple Rules *Age in yr minus Downloaded from www. fosavance. ae OST - Caucasians Simple Rules *Age in yr minus weight in kg 30

Downloaded from www. fosavance. ae SUMMARY • Both OST and OSTA performed well – Downloaded from www. fosavance. ae 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 31