Hip Fracture Registry of Thailand (A Pilot Project & Interim Analysis) MBOG Annual Meeting 2015 โรงแรมเจริญธานี ขอนแก่น 12-13 พย. 59 เวลา 15:30-16:00 Sattaya Rojanasthien MD Department of Orthopedics Faculty of Medicine Chiang Mai University, Thailand

Incidence of Hip fracture in Chiang Mai 1997 & 2006 Crude Incidence of Hip Fracture in Chiang Mai Province (per 100,000) The overall crude incidence increased 2.02% per year Phadungkiat S, et al. J Med Assoc Thai 2002 May;85(5):565-71. Wongtriratanachai P, et al. J Clin Densitom 2013 Jul-Sep;16(3):347-52.

Age-specific Incidence of Hip Fracture in Chiang Mai 2006 690 hip-fracture patients within one year period Patients aged ≤ 60 had low incidence of hip fracture in 1997 & 2006 studies Exponential increase can be seen after age of 70 Wongtriratanachai P, et al. J Clin Densitom 2013 Jul-Sep;16(3):347-52.

Mechanism of Hip Fracture 691 hip fracture patients in 2006 79% The most commom mechanism of hip fracture was a simple fall which was 79 % of patients Wongtriratanachai P, Luevitoonvechkij S, Songpatanasilp T, Rojanasthien S. JCD 2013 Funding by TOPF, Acknowledgement to all Orthopaedists in Chiang Mai

Mortality and Median Survival Time after Osteoporotic Hip Fracture in Chiang Mai, Thailand 12 Long-term (1998 to 2007) survival analysis of 367 osteoporotic hip fracture patients, mean age 74 yrs Ten-year mortality was 68 % One-year mortality was 18% that was 8 times higher than age-matched general population One-year mortality (%) Median survival time (months) Male 31 40 Female 16 84 Overall 18 72 Vaseenon T, Luevitoonvechkij S, Wongtriratanachai P, Rojanasthien S. Journal of Clinical Densitometry. 2010, Vol 13

Associated Factors of Death after Hip fracture Hazard ratio (95% CI) P Value Age (yr) <70 70-80 >80 1 1.45 (1.03-2.03) 1.90 (1.39-2.63) 0.030 <0.001 Gender Male Female 1.72 (1.20-2.50) Type of treatment Operative Nonoperative 1.81 (1.29-2.54) 0.001 Antiresorptive agents 0.73 (0.37-1.42) 0.354 Tanawat Vaseenon , Sirichai Luevitoonvechkij, Prasit Wongtriratanachai, Sattaya Rojanasthien. Journal of Clinical Densitometry. vol 13, 2010

at Maharat Nakhon Ratchasima Hospital Mortality and ambulatory status after intertrochanteric fracture treated at Maharat Nakhon Ratchasima Hospital A retrospective cohort study of 496 intertrochanteric fracture patients at least 60 years of age, treated between October 2002 and September 2006 (4 years) overall one-year mortality rate 23.6% median survival time 4.18 years at 2 years: 55% walk independently, 28% needs walking aid, 17% wheelchair or confined to bed Home traction 245, operation 251 Associated Factors Odd Ratio P Value 95% CI Traction vs operation 3.00 0.000 1.86-4.86 Female vs male 0.48 0.003 0.29-0.77 Age per year of increase 1.05 0.001 1.02-1.08 Lewsirirat S, Thanomsingh P. JRCOST VOL.34 NO. 3-4 July-October 2010

One-year Mortality after Hip Fracture in Chiang Mai on different period of Time Chaysri R, Leerapun T, Klunklin K, Chiewchantanakit S, Luevitoonvechkij S, Rojanasthien S. J Med Assoc Thai 2015; 98 (1): 59-64.

Hip Fracture Registry Initiative in Thailand Multi-center, hospital-based, prospective observational, epidemiological study was conducted since October 2010 in 7 tertiary care hospitals The primary objective: To determine the rate of subsequence osteoporotic fractures within 1 year after hip fracture in clinical practice in Thailand The secondary objectives: To determine treatment-related outcomes of hip fracture treatments To describe epidemiological data of hip fracture patients in Thailand Srinagarind Hospital Ramathibodi Hospital Siriraj Hospital King Chulalongkorn Memorial Hospital Phramongkutklao Hospital Chiang Mai University Hospital Police General Hospital | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

| NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE Study Design Observational , multicenter trial in 7 tertiary care hospitals Thai male or female 50 year of age or older Clinical osteoporosis hip fracture determine by radiographic verification (radiographic report or review/confirmation of radiograph by the study investigator) Treatments or prescriptions were based on routine clinical care under uncontrolled conditions One-year data collection Patients demography, surgical treatment, osteoporosis treatment, cost, complications | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

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Baseline & Follow-up Visit Parameters   Total number of patients of Baseline visit 664 Follow-up period (n=565) Median (months) 2.79 Mean (months) 3.82+3.02 Range (months) 0.30 – 12.0 Time between baseline visit to visit 1 1.21 1.44+1.1 0.30 – 10.10 No. of patients completed 1 year follow-up 61 Median (Min,Max) follow-up visits 2 (1, 9) Total person-years under observation 261.1 | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

Baseline Characteristics 7 Study Sites (n = 664) Age (years) (n=664)       Mean (SD) 77.7 (9.4)     Median (Min:Max) 78.7 (50.0: 100) 50 – 70 134 20.2% 71 – 80 269 40.5% 81 or greater 261 39.3% Gender, Responded (n=663) (1 : 2.9)     Male:Female 169:494 25.5%:74.5% Smoking status, Responded (n=657) Current smoking 17 2.6% Alcohol intake, Responded (n=657) Current intake 22 3.4% Steroid intake, Responded (n=621) Current intake ≧ 7.5 mg/day 3 0.5% | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

Baseline Characteristics 7 Study sites (n=664) Weight (kg), Responded (n=536)     Mean (SD) 51.2 (10.8)     Median (Min:Max) 51.5 (30 : 88) Height (cm), Responded (n=534) 156.5 (8.4) 155 (120 : 180) Body mass index (BMI), Responded (n = 532) 21.9 (3.7) 21.7 (12.9 : 35.6) Less than 18.5 87 16.3% 18.5 – 22.9 258 48.5% 23.0 – 30.0 or greater 187 35.2% | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

Previous History of Hip Fracture (parental or self) Characteristics 7 Study sites (n=664) Hip fracture – family history, Responded (n=650) Parenteral hip fracture 19 2.9% Hip fracture – self history, Responded (n=648) Patients with previous fracture (any fractures) 109 16.8% Hip fracture (43.1% of any fracture) 47 7.1% of total Characteristics 7 Study sites (n=664) Patient with previous fracture (any fractures) Patients with previous hip fracture only Patients with previous fractures 109 16.4% of 664 47 7.1% of 664 Patients received OP treatment (one patient might receive ≥ one drug) 52 47.1% of 109 20 42.6% of 47 | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

Location of Hip Fracture Characteristics 7 Study sites (n=664) Diagnosis of hip fracture, Responded (n=655)   Femoral neck hip fracture 312 47.0% Intertrochanteric hip fracture 306 46.1% Subtrochanteric hip fracture 32 4.8% Atypical subtrochanteric hip fracture 5 0.8% | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

| NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE Treatment Method Characteristics 7 Study sites (n=664) Fracture treatment (n=664) Patients underwent non-operation 93 14.0% Patients underwent operation 571 86.0% Fixation 297 44.7% Hemiarthroplasty 248 37.4% Total hip replacement 22 3.3% Other operation techniques 4 0.6% | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

New Fracture within 1 year Kaplan-Meier survival analysis Complications Person-year Events Rate/100 patients per year 95%CI Lower limit Upper limit New fracture 258.1 11 4.3 2.4 7.7 Eleven (11) new fracture includes Six (6) new hip fractures Femoral neck (3) Intertrochanteric (3) One (1) spine Four (4) others | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

Complications within 1 year (n =1,036) Person-years Events Rate/100 patients per year 95%CI Lower limit Upper limit Any 249.6 56 22.4 17.3 29.2 Death 261.1 12 4.6 2.6 8.1 Stroke 260.4 2 0.8 0.2 3.1 DVT 260.6 1 0.4 0.1 2.7 CHF 260.9 MI 4 1.5 0.6 4.1 Electrolyte imbalance 258.5 9 0.03 0.01 Pulmonary embolism 0.0 GI bleed Deep infection 259.7 7 1.3 5.7 Superficial infection 5 1.9 New fracture 258.1 11 4.3 2.4 7.7 | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

Cost-utility Analysis of Osteoporotic Hip Fractures in Thai Data: From January 1, 2008 to December 31, 2008 at Ramathibodi Hosp. Inclusion: Osteoporotic hip fracture patients, aged ≥51 Result is lower than other developed countries due to Strong family support Insufficient rehabilitation program Cost (Baht) QALY Cost/QALY (USD)* Total Cost 126,319.5 0.636 198,615.57 6,620.52 Direct Cost 60,558.3 95,217.45 3,173.92 *30 Baht = USD Wajanavisit W, et al. J Med Assoc Thai 2015; 98 (Suppl. 8): S65-S69.

TREATMENT-RELATED EXPENSE Characteristics Expense (Baht) Mean (SD) total treatment expense (n = 483) 73,970.01 (46,909.78) Median (Min:Max) total treatment expense 65,004 (2,986:421,685) Mean (SD) implantation cost (n=381) 26,228 (37,356.89) Median (Min:Max) implantation cost 20,493 (0:653,786) Mean (SD) total medication cost (n=267) 22,944.17 (22,933.0) Median (Min:Max) total medication cost 17,193.5 (0 : 245,868.5) Mean (SD) osteoporotic medication cost (n=232) 503.4 (44,73.2) Median (Min:Max) osteoporotic medication cost 34.8 (0 : 65,000) | DATA ON FILE | PLEASE DO NOT CITE OR QUOTE

| NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE Conclusion Incidence of hip fracture in Thailand is increasing Average age of hip fracture is increasing One year all causes mortality after hip fracture is also increasing Hip Fracture Registry Initiative, pilot study of 7 tertiary care hospitals 664 cases, average age 77 years, 80% aged over 70 years Male : Female = 1 : 2.9 Mean FU was very short as 3.8 months Most were treated by surgery Half by fixation, half by arthroplasty Refracture rate was 4.3/ 100 persons year Mortality was the most common complication: 4.6 / 100 persons year Further analysis for OP treatment rate, Expense, Mortality, Success or failure of internal fixation and arthroplasty | NOVARTIS DATA ON FILE | PLEASE DO NOT CITE OR QUOTE