Distal Radius Fracture Risk Reduction With a Comprehensive Osteoporosis Management Program

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1 SCIENTIFIC ARTICLE Distal Radius Fracture Risk Reduction With a Comprehensive Osteoporosis Management Program Neil G. Harness, MD, Tadashi Funahashi, MD, Richard Dell, MD, Annette L. Adams, PhD, MPH, Raoul Burchette, PhD, Xuan Chen, PhD, Denise Greene, BS Purpose To study risk factors associated with osteoporotic distal radius s and evaluate the effectiveness of the screening and treatment components of a comprehensive osteoporosis program. Methods We retrospectively identified a cohort of patients aged 60 years or older from a large health maintenance organization. For the period 2002 to 2008, information on age, race, sex, diabetes status, osteoporosis diagnosis, osteoporosis screening activity, medications dispensed, and events, including distal radius, proximal humerus, and hip s were recorded. We compared demographic and clinical characteristics for patients with and without distal radius s. We estimated multivariable estimates of the associations between pharmacologic treatment, and osteoporosis screening and distal radius risk using Cox proportional hazards methods, and adjusted them for age, sex, race, diabetes status, and prior history of hip or proximal humerus s. Results Overall, 1.7% of the cohort (n 8,658) of the study population (N 524,612) sustained a new distal radius during 2002 to In the multivariable model, we found that patients who received pharmacological intervention were 48% less likely to sustain a distal radius. Similarly, patients who were screened for osteoporosis were 83% less likely to sustain a distal radius. Patients with osteoporosis were 8.9 times more likely to have a distal radius than patients without osteoporosis. White subjects had a 1.6 times higher risk of distal radius than non-whites, and women had a 3.8 times higher risk than men. Conclusions White race, female sex, and a diagnosis of osteoporosis are high risks for distal radius. Screening for and pharmacologic management of osteoporosis using a multidisciplinary team approach in a comprehensive osteoporosis management program resulted in a statistically significant decrease in the risk of distal radius. (J Hand Surg 2012;37A: Copyright 2012 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic III. Key words Osteoporosis,, distal radius, treatment. From the Department of Orthopaedic Surgery, Southern California Permanente Medical Group, Kaiser Orange County Medical Center, University of California Irvine, Orange; the Southern California PermanenteMedicalGroup,DowneyMedicalCenter,Downey;andtheDepartmentofResearchandEvaluation, KaiserPermanenteSouthernCalifornia, Pasadena, CA. Received for publication May 13, 2011; accepted in revised form April 24, No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Correspondingauthor:NeilG.Harness,MD,DepartmentofOrthopaedicSurgery,SouthernCalifornia Permanente Medical Group, Kaiser Orange County Medical Center, University of California Irvine, 3460 E. La Palma Avenue, Anaheim, CA; neil.g.harness@kp.org /12/37A $36.00/ ASSH Published by Elsevier, Inc. All rights reserved. 1543

2 1544 OSTEOPOROSIS AND DISTAL RADIUS FRACTURE OSTEOPOROSIS IS CHARACTERIZED BY a loss of bone mineral density (BMD), which increases the risk of after low-energy trauma. 1 Distal radius s are the most common upper extremity in patients over the age of 65 years. 2 Several studies have documented the increased risk of a distal radius in patients with decreased BMD. 3 5 In addition, a history of a prior forearm is associated with a nearly 3-fold increased risk of a future of the hip, spine, wrist, proximal humerus, and pelvis, compared with what is expected in the general population. 6 Patients with low-energy distal radius s have a lower BMD than age-matched controls, 7 12 and as the BMD decreases, the severity of distal radius increases. 13 Therefore, prophylactic treatment of osteoporosis may result in the prevention of these injuries and may reduce their severity. Treatment for osteoporosis after a distal radius can also decrease the risk of a subsequent fragility. A meta-analysis has shown that treatment of women with osteoporosis with a medication that inhibits bone turnover such as bisphosphonates can reduce the relative risk of of the hip and distal radius. 14 There are multiple medications and supplements aimed at improving BMD and decreasing risk. Calcium and vitamin D supplements, hormone therapy, calcitonin, and bisphosphonates have varied degrees of effectiveness and side effects. 15 Bisphosphonates have been shown in multiple studies to increase BMD and decrease risk in patients with osteoporosis Because of their effectiveness, bisphosphonates have become a standard component of osteoporosis treatment plans. Although a number of studies have addressed the effectiveness of bisphosphonates on reduction of risk for hip and spine s, no large population-based investigations have addressed the effectiveness of these medications on the reduction of risk for distal radius s. An understanding of the epidemiology of these s has focused on efforts to predict which patients are at greatest risk for fragility and the best method to implement preventative treatment. A study in 1995 found that non-hip s account for a substantial number of osteoporotic s in the United States (37%) and represent a large portion of the annual health care expenditure ($5 billion). 21 Accurately stratifying and identifying patients at risk for distal radius s could allow us to treat and potentially reduce the incidence, associated morbidity, and health care costs of these injuries. Such a preventative treatment strategy must address the factors that contribute to the risk of osteoporosis and osteoporotic s, including low BMD and nutrition, while balancing the costs of prevention against the costs of treatment. The first purpose of this study was to evaluate the risk of distal radius in a large population of patients based on specific epidemiologic factors including age, race, sex, diabetes status, osteoporosis status, osteoporosis screening status, and history of prior fragility. The second purpose was to evaluate the effectiveness of the screening and treatment components of a comprehensive osteoporosis program implemented in a large health maintenance organization. MATERIALS AND METHODS Study design and setting A retrospective cohort study was performed, including all Kaiser Permanente Southern California (KPSC) enrollees who were aged 60 years or older as of January 1, KPSC is a not-for-profit community service health care organization providing care to approximately 3.3 million members. In 2002, the KPSC region began implementing the Healthy Bones Model of Care (HBMOC), an interdisciplinary osteoporosis prevention and management program. This program seeks to identify health plan members who are at increased risk for developing osteoporosis and fragility s and provides proactive screening, prevention, and treatment options. Members selected for enhanced screening are women aged 65 years or older; men aged 70 years or older; and all patients 50 years of age and older who have a personal history of fragility since age 50, glucocorticoid use for 3 or more months at doses of 5 mg or greater, parental history of hip, rheumatoid arthritis, high alcohol use (3 or more ounces per day), a history of cigarette smoking, and other causes of secondary osteoporosis. Members identified as being at increased risk are screened by dual-energy x-ray absorptiometry scan. Prevention and treatment options include screening for vitamin D deficiency and vitamin and mineral supplementation; use of evidencebased pharmacologic interventions; lifestyle changes, such as increased exercise and smoking cessation; and fall-reduction interventions, such as classes and fall-proofing homes. Study measures For each cohort member, we collected from electronic administrative and clinical data sources: (1) demographic information, including age, sex, and race/ethnicity; (2) enrollment information; (3) inpatient and outpatient encounter information, including diagnosis and procedure codes for each encounter; (4) claims

3 OSTEOPOROSIS AND DISTAL RADIUS FRACTURE 1545 information from outside providers; (5) referral information; (6) radiology records; and (7) pharmacologic treatments. We ascertained diabetes status, osteoporosis status, osteoporosis screening status, and history of prior fragility s from inpatient and outpatient encounter data before cohort inception. Outcome measure. For each subject, we identified the first occurrence of a distal radius occurring between 2002 and 2008 by International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM) discharge diagnosis codes to We excluded patients with a history of distal radius before 2002 from the analysis. Exposure measure. We assessed 2 components of the HBMOC for their association with distal radius incidence: screening for osteoporosis and pharmacological intervention for osteoporosis. Patients were considered to have been screened for osteoporosis if they had a BMD test conducted during the study period, regardless of the BMD test results. Patients were considered to have received pharmacological intervention for osteoporosis if they had been prescribed bisphosphonates, calcitonin, estrogens, selective estrogen receptor modulators, miscellaneous hormones, and sex hormone combinations. Calcium and vitamin D are recommended medications for all patients with osteopenia and osteoporosis in the HBMOC, but we did not consider them in the data analysis because they cannot be captured as a prescription medication. For patients who subsequently sustained a distal radius, the prescriptions had to have predated the by at least 6 months for the patient to be considered exposed before the. Covariates and potential confounders. We categorized age as 60 to 69 years, 70 to 79 years, and 80 years or older for descriptive purposes, and entered them as a continuous variable in multivariate models. We dichotomized race as white versus non-white because the health plan did not collect further delineation in racial data during this study period. We identified the diagnosis of osteoporosis from clinical data and hospital discharge data. Patients were classified as having osteoporosis when they had an ICD-9-CM discharge diagnosis recorded with code 733.0x (osteoporosis) or had a BMD test score indicating osteoporosis or low bone mass requiring treatment (women: t-score 2.0; men: t-score 2.5) any time during the study period. We also used hospital discharge diagnosis codes to identify s of the hip (ICD-9-CM codes 820.xx) or proximal humerus (ICD-9-CM codes ) and validated them by chart review. These s must have occurred before the distal radius to be considered a risk factor for distal radius s. As with the distal radius outcomes, all reports of hip or proximal humerus were validated by chart review. Statistical analysis We described patient demographic and clinical characteristics using counts and proportions for categorical data and means or medians for continuous data. We used the chi-square test of proportions to compare the proportions of patients with incident distal radius s by demographic categories, osteoporosis diagnosis categories, screening status for osteoporosis, and pharmacological intervention for osteoporosis. All reported P values are 2-sided. We set the statistical significance level at alpha To estimate the associations between the osteoporosis management program indicators (pharmacological treatment for osteoporosis and screening status for osteoporosis) and incident distal radius s, we built multivariable models using Cox proportional hazards methods, adjusting for age, race, sex, diabetes status, and history of prior hip or proximal humerus s. We censored subjects at death or on disenrollment from the health care plan. We also considered a priori the possibility that screening status and treatment status might interact in a way affecting the outcome. Therefore, we also built a multivariable model that included combinations of screening and treatment status, adjusted for the same covariates listed above. This study was reviewed and approved by the KPSC institutional review board. RESULTS As of January 1, 2002, we identified 524,612 patients within KPSC who were at least 60 years of age. Overall, 1.7% of the cohort (n 8658) sustained a new distal radius during the study period, 2002 to Distal radius s were more common among women (2.5% vs 0.7% for men; P.001) and white patients (2.1% vs 1.2% for non-white patients, P.001). Distal radius occurrence was most common in the oldest patients, occurring in 2.5% of those 80 years of age and older. Both the screened group and the treated group were more likely to be female, white, and diagnosed with osteoporosis, and to have had previous hip or proximal humerus s, compared with the unscreened and untreated groups, respectively (Table 1). Considering

4 1546 OSTEOPOROSIS AND DISTAL RADIUS FRACTURE TABLE 1. Demographics and Clinical Characteristics of a Cohort at Risk for Sustaining Incident Distal Radius Fractures, by Screening and Treatment Status for Osteoporosis, Screening Status Treatment Status Overall Screened Unscreened Treated Untreated Total 524,612 (100.0) 175,875 (33.5) 348,737 (66.5) 154,930 (29.5) 369,682 (70.5) Female 278,919 (53.2) 142,250 (80.9) 136,669 (39.2) 140,049 (90.3) 138,870 (37.6) White 233,519 (44.5) 92,220 (52.4) 141,299 (40.5) 80,857 (52.2) 152,662 (41.3) Age y 302,231 (57.6) 100,019 (56.9) 202,302 (58.0) 85,307 (55.1) 217,014 (58.7) Age y 158,424 (30.2) 59,497 (33.8) 98,927 (28.4) 50,716 (32.7) 107,708 (29.1) Age y 63,867 (12.2) 16,359 (9.3) 47,508 (13.6) 18,907 (12.2) 44,960 (12.2) Distal radius 8,658 (1.7) 2,595 (1.5) 6,063 (1.7) 3,403 (2.2) 5,255 (1.4) Screened 175,875 (33.5) 108,810 (70.2) 67,065 (18.1) Treated 154,930 (29.5) 108,810 (61.9) 46,120 (13.2) Osteoporosis diagnosis 83,809 (16.0) 73,092 (41.5) 10,717 (3.1) 67,796 (43.7) 16,013 (4.3) Diabetes mellitus 120,796 (23.0) 39,796 (22.6) 81,000 (23.2) 32,107 (20.7) 88,689 (24.0) Previous hip 10,541 (2.0) 4,577 (2.6) 5,964 (1.7) 6,289 (4.1) 4,252 (1.2) Previous proximal humerus 6,158 (1.2) 3,400 (1.9) 2,758 (0.8) 3,361 (2.2) 2,797 (0.8) TABLE 2. Demographic and Clinical Characteristics of a Cohort at Risk for Sustaining Incident Distal Radius Fractures, by Combinations of Screening and Treatment Status, Unscreened-Untreated Unscreened-Treated Screened-Untreated Screened-Treated Total 302,617 (57.7) 46,120 (8.8) 67,065 (12.8) 108,810 (20.7) Female 95,648 (31.6) 41,021 (88.9) 43,222 (64.5) 99,028 (91.0) White 118,484 (39.2) 22,815 (49.5) 34,178 (51.0) 58,042 (53.3) Age y 178,354 (58.9) 23,948 (51.9) 38,660 (57.7) 61,359 (56.4) Age y 85,037 (28.1) 13,890 (30.1) 22,671 (33.8) 36,826 (33.8) Age y 39,226 (13.0) 8,282 (18.0) 5,734 (8.5) 10,625 (9.8) Distal radius 4,485 (1.5) 1,578 (3.4) 770 (1.2) 1,825 (1.7) Osteoporosis diagnosis 3,733 (1.2) 6,984 (15.1) 12,280 (18.3) 60,812 (55.9) Diabetes mellitus 70,725 (23.4) 10,275 (22.3) 17,964 (26.8) 21,832 (20.1) Previous hip 3,319 (1.1) 2,645 (5.7) 933 (1.4) 3,644 (3.4) Previous proximal humerus 1,887 (0.6) 871 (1.9) 910 (1.4) 2,490 (2.3) screening and treatment jointly, however, we found some important differences among the 4 groups. The group that was both screened and treated was more likely to be female and white, to be diagnosed with osteoporosis, and to have a history of prior proximal humerus s, compared with the other combinations of screening and treatment (Table 2). Those who were treated but not screened were more likely than all other groups to have had a prior hip (5.7%; n 2645). We automatically entered these patients into the HBMOC and started them on bisphosphonate treatment by protocol. Adjusting for age, sex, race, history of diabetes, history of prior hip or proximal humerus, and diagnosis of osteoporosis, we found that having been screened for osteoporosis was strongly associated with a reduction in the risk of incident distal radius, relative to the unscreened group (hazard ratio [HR], 0.17;

5 OSTEOPOROSIS AND DISTAL RADIUS FRACTURE 1547 TABLE 3. Risk of Incident Distal Radius Fracture from the Cox Proportional-Hazards Model HR (95% CI) Main effects model 0.52 ( ) Medication treatment Screened for osteoporosis 0.17 ( ) Diagnosed with osteoporosis 8.94 ( ) Age, continuous 1.01 ( ) Female 3.77 ( ) White 1.62 ( ) Diabetes mellitus 1.05 ( ) Proximal humerus, previous 1.37 ( ) Hip, previous 0.93 ( ) Interaction model Screened and treated 0.09 ( ) Unscreened but treated 0.52 ( ) Screened but untreated 0.17 ( ) Unscreened and untreated 1.00 Diagnosed with osteoporosis 8.96 ( ) Age 1.01 ( ) Female 3.77 ( ) White 1.63 ( ) Diabetes mellitus 1.05 ( ) Proximal humerus, previous 1.37 ( ) Hip, previous 0.93 ( ) 95% confidence interval [CI], ). Receipt of pharmacological intervention for osteoporosis was also strongly associated with a reduction in the risk of distal radius, relative to patients who had not received medication treatment (HR, 0.52; 95% CI ) (Table 3). In the multivariable model that included discrete combinations of screening and treatment status, we found that compared with the unscreened and untreated group, all other groups were at substantially reduced risk for incident distal radius (Table 3); screening and treatment combined were most strongly protective against incident distal radius (HR, 0.09; 95% CI, ) (Table 3). DISCUSSION As the percentage of the US population over the age of 65 increases, the impact of osteoporotic s on the health care system will be substantial. It has been shown that patients with distal radius s tend to have a lower BMD than age-matched controls Low BMD increases the risk of, increases the severity of the pattern, and subsequently influences the outcome of treatment. 22 Thus, the use of a comprehensive osteoporosis management program with BMD scanning is critical to help identify and treat individuals at risk for a distal radius. In the current study, s occurred more frequently in white women, and the risk increased with age. Patients with osteoporosis were almost 9 times more likely to sustain a distal radius compared with patients without osteoporosis. There was a reduction in the risk of incident distal radius among those who were screened, relative to the unscreened group. Pharmacological intervention for osteoporosis was also strongly associated with a reduction in the risk of distal radius relative to patients who had not received medication treatment. When we analyzed the data using a multivariable model, the group that underwent screening and treatment had the greatest reduction in risk of distal radius. This evidence supports the use of health care resources to develop more robust screening and treatment programs to help prevent distal radius s. Smaller studies have shown a similar pattern of reduced risk with a comprehensive osteoporosis program. The Geisinger Health System was the first to show that an osteoporosis disease management program could lead to a decrease in hip rate and the associated costs of care. The study population consisted of 22,171 women over the age of 55 years. The ageadjusted incidence rate of hip s changed from 7.9 to 5.1 per 1,000 person-years over a 5-year period after implementation of the program. 23 Other studies have confirmed that with appropriate treatment of osteoporosis, risk may be reduced by 40% to 60%. 21 The use of alendronate in 1,022 osteoporotic women with prior vertebral reduced the risk of distal radius by nearly 50%, 16 whereas another study of 3,658 osteoporotic women with or without prior vertebral found that the risk was reduced by 30% by taking alendronate. 24 The hazard ratio reported in the former study was 0.52, which is the same as that observed in the current study of 524,612 patients. Although the treatment of osteoporosis has been clearly shown to reduce the risk of fragility s, the implementation of screening and treatment guidelines has been inconsistent. 21 The rate of evaluation and management of osteoporosis is poor after most fragility s but is particularly poor after those of the distal

6 1548 OSTEOPOROSIS AND DISTAL RADIUS FRACTURE radius 10,21,25 ; nevertheless, the rate of evaluation and management improves when subspecialty and primary care providers work in a coordinated fashion. 10 A comprehensive program that leverages a large organization s electronic medical record along with an integrated team of nurses, physician assistants, and orthopedic surgeons is likely to result in the highest rates of patient screening and treatment. Since its inception in 2002, the HBMOC program greatly increased screening and treatment rates, leading to a 41% reduction in hip s and more than 250 saved lives each year. 23,26 It is estimated that the HBMOC has resulted in a $30.8 million reduction in the annual treatment costs for such s, which considerably outweighs program costs. 27 A more detailed analysis of the program is available through the US Department of Health and Human Services Agency for Healthcare Research and Quality. 26 The current study has some important limitations that must be considered in interpreting the results. We collected the data retrospectively and took them from large administrative databases, which have inherent limitations in the capture rate of s, screening status, and treatment intervention. The subjects in this study were not randomized to either screening or treatment but were referred based on known or perceived risk factors for osteoporosis or fragility s, including a prior hip or proximal humerus. Although our multivariable models adjust for some wellestablished risk factors for osteoporosis and fragility, we may still have some residual bias as a result of confounding by indication, where we have not adequately adjusted for other factors related to both the receipt of screening or treatment and the likelihood of. The data for pharmacologic intervention must be interpreted with caution, because the medications were not stratified to the specific type; yet patients were prescribed bisphosphonates, calcitonin, estrogens, selective estrogen receptor modulators, miscellaneous hormones, and sex hormone combinations. The use of bisphosphonates has become the standard for treatment of osteoporosis within KPSC over the last decade, and the percentage of patients taking hormone derivatives is likely low. It is also possible that patients received pharmacologic treatment outside KPSC and would not be recorded in the pharmacy records; however, the number of patients who obtain medications outside KPSC through alternate health care coverage is likely low and is unlikely to affect the overall result. Moreover, we did not address the monitoring of medication compliance in this study. These limitations are inherent in a study population of this size, but they should be considered in the overall interpretation of the results. Given the enormous economic, physical, and emotional impact that distal radius s have on patients and the stress they place on the health care system, it is imperative that we establish methods to adequately screen and treat patients at risk. 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