1. UNDERTREATMENT AMONG WOMEN DIAGNOSED WITH OSTEOPOROSIS IN GERMANY Ankita Modi 1, Chun-Po Steve Fan 2, Shuvayu Sen 1 1 Global Health Outcomes, Merck & Company, NJ, 2 AsclepiusJT LLC, NY Introduction Osteoporosis is common in Germany. Based on WHO definition of reduced bone mineral density measurement (DXA T-score ≤–2.5), about 7% post-menopausal women aged ≥ 55 experienced osteoporosis. It is increased to 19% at age 80. 1 Osteoporosis is under-treated and imposed a considerable economic burden on the healthcare system in Germany. In 2003, 7.8 million Germans (6.5 million women) were affected by osteoporosis. Only 21.7% were treated with an osteoporosis medication. The total direct costs attributable to osteoporosis amounted to euros 5.4 billion. 2 Pharmacological agents currently used for the treatment of osteoporosis in Germany include alendronate, ibandronate, risedronate, zoledronic acid, strontium, calcitonin, raloxifene, teriparatide, and, most recently, denosumab. 1 Drug treatment is recommended regardless of age and gender if the estimated 10-year risk of vertebral and hip fractures is > 30 % and the T-scores of the DXA bone mineral density measurement at the lumbar spine, the total hip or the femoral neck are reduced. 1 Methods Study design A retrospective cohort study using Germany IMS Lifelink TM Electronic Medical Records (formerly Mediplus Germany) from January 1, 2001 to December 31, 2010 (study period). Index date was defined as the first date of OP diagnosis in the study period. The one-year period before the index date was defined as the pre-index period. The post-index period was defined as the one- year period after the index date. The number and percent of individuals receiving pharmacological treatment within one year (during post-index period) after index date were determined in this population. References 1.DVO Guideline 2009 for Prevention, Diagnosis and Therapy of Osteoporosis in Adults. Germany Dachverband Osteologie. Osteologie 2011; 20: 55–74 2.Häussler B, Gothe H, Göl D. Epidemiology, treatment and costs of osteoporosis in Germany--the BoneEVA Study. Osteoporos Int. 2007 Jan;18(1):77-84.. Treatment with osteoporosis medications During the post-index period, 15,632 patients (83.1%) received no osteoporosis medication within one year after diagnosis (Figure 2). Of the 3,181 patients (16.9%) who received treatment, 2,856 (15.2%) received bisphosphonates and 325 (1.7%) received non- bisphosphonates as the first OP treatment (Figure 2). The most frequently used bisphosphonate was alendronate (10.7%), followed by risedronate (3.9%) and ibandronate (0.6%). Raloxifene (1.0%) and strontium (0.4%) were the most frequently used non-bisphosphonates. Variables associated with Osteoporosis treatment initiation Table 2 shows the untreated population is younger than the treated population (71.3 vs. 72.4, p-value <.0001). There were fewer women who had fractures before the diagnosis of osteoporosis in the untreated population than the treated population (2.9% vs. 6.5%, p-value<.0001). Untreated population were taking less NSAIDs, corticosteroids, and gastro-protective agents compare to treated population in the pre- index period (33.8% vs. 43.0%; 16.0% vs. 20.9%; 16.6% vs. 25.4%, all p-value <.0001) Table 2. Comparison of baseline patient characteristics in treated vs. untreated patients A Table 1. Patient characteristics in the pre-index period A Figure 2. Distribution of patients by treatment initiation Study sample Women ≥ 55 years as of index date, who had a diagnosis of OP based on ICD-10-CM codes (M81, M82) during study period, and were continuously enrolled in the health plan for at least one year before and one year after the index date were included in the study. Subjects were excluded if they had a claim for any osteoporosis medication before the index date; estrogen use in the pre-index period; or ever had a diagnosis of Paget’s disease or malignant neoplasm. Conclusions Among women 55 years or older diagnosed with osteoporosis in Germany, a significant proportion i.e., 83.1 % did not receive any pharmacological treatment within one year after being diagnosed with osteoporosis. Pre-existing conditions, such as gastrointestinal problems, hypertension, chronic inflammatory joint disease and diabetes mellitus may be associated with treatment initiation. Further research is needed to understand barriers to treatment despite osteoporosis diagnosis. Figure 1. Patient selection Objective To describe characteristics and treatment initiation among women diagnosed with osteoporosis (OP) in Germany Data analysis Pharmacological treatment for OP were identified based on ATC-4 classification and included all forms of bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid) and non- bisphosphonates (calcitonin, strontium, raloxifene, and teriparatide). Denosumab was not considered in the analysis because the approval date was beyond the study period. Patients were characterized as 'treated' if they received ≥ 1 OP treatment during the post index date period. Number and percent of patients receiving OP treatment were determined in this population. Patient characteristics such as age, charlson comorbidity index, osteoporosis fracture history, gastrointestinal problem history, corticosteroid use, NSAID use, Gastro-protective agents use, and related comorbidities in the pre-index period were assessed for all patients. Gastrointestinal (GI) problems under consideration include esophagitis, esophageal reflux (GERD),ulcer, stricture, perforation, hemorrhage of esophagus, gastric ulcer, duodenal ulcer, peptic ulcer, acute gastritis, duodenitis, GI hemorrhage, nausea, vomiting and dysphagia. Differences in baseline patient characteristics were assessed by Wilcoxon rank-sum tests for continuous variables and Chi-square tests for binary/categorical variables among the treated and non- treated groups. N = 88,337 Patients with a diagnosis of osteoporosis The first diagnosis date of OP is defined to be the index date. N= 65,624 Patients who are female, and age of 55 or above as of the index date N = 63,625 Patients who are naive to OP medication anytime prior to the index date N = 22,626 Patients with at least 12-month continuous eligibility before and after the index date N = 18,813 (TOTAL SAMPLE) Exclude patients with estrogen use, diagnosis of malignant neoplasm or Paget’s disease of bone European Congress on Osteoporosis and Osteoarthritis Rome, Italy April 17-20, 2013 Results Patient characteristics The study population comprised 18,813 women who met study inclusion criteria (Figure 1). The average age [SD] at diagnosis was 71.4 [9.2] years (Table 1). Osteoporosis fractures were recorded for 3.5% of subjects in the pre-index period (prior to receiving the first OP diagnosis). Approximately 13.8% of women had a history of gastrointestinal problems in the pre-index period (Table 1). Hypertension, depression, and diabetes mellitus were identified as common pre-index comorbidities in this sample (Table 1). GI, gastrointestinal; SD, standard deviation; NSAID, non-steroidal anti-inflammatory drug. A Values are presented as N (%) unless otherwise indicated. GI, gastrointestinal; SD, standard deviation; NSAID, non-steroidal anti-inflammatory drug. A Values are presented as N (%) unless otherwise indicated. Poster P442