Adherence of bisphosphonate and decreased risk of clinical vertebral fracture in osteoporotic patients: A propensity score matching analysis

Objectives@#Bisphosphonate is associated with a decreased risk of vertebral fractures due to osteoporosis. However, there are limited studies on how poor compliance with bisphosphonate affects the risk of vertebral fractures in a nationwide cohort. We aim to evaluate whether adherence to bisphosphonate affects the risk of fracture in osteoporosis patients. @*Methods@#We used the data of the Korean National Health Insurance Service Senior Cohort. A total of 33,315 (medication possession ratio [MPR]: 50) osteoporosis patients were matched using the propensity score matching method: those who received low-dose bisphosphonate and those who received highdose bisphosphonate. Twenty-two confounding variables, including age, socioeconomic status, medications prescribed, and underlying diseases that may affect the risk of fracture were adjusted for propensity score matching. The risk of vertebral fracture was assessed by Cox proportional hazards regression. @*Results@#Patients with a higher MPR showed a decreased vertebral fracture risk than those with a lower MPR (MPR 50 ¼ hazard ratio [HR] 0.909; 95% confidence interval [CI] 0.877e0.942 P < 0.001; MPR 70 ¼ HR: 0.874, 95% CI: 0.838e0.913, P < 0.001; MPR 90 ¼ HR: 0.822, 95% CI: 0.780e0.866, P < 0.001). MPR was associated with a decreased vertebral fracture risk in both groups with or without history of fracture. In the subgroup analysis, MPR was associated with a decreased vertebral fracture risk in women, in all ages, with or without T2DM, and with or without hypertension. @*Conclusions@#Higher MPR is associated with a lower vertebral fracture risk.

Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study

Background@#This phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis. @*Methods@#Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤–2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months. @*Results@#At month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (–0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P<0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively. @*Conclusion@#Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).

The secular trends in the use of medications for osteoporosis in South Korea using Intercontinental Medical Statistics Health Sales Audit 2006-2018

Objectives@#Osteoporosis medications are widely available in South Korea, and well reimbursed by the Government Health Insurance; however, some expensive drugs are not reimbursed. The prescription of anti-osteoporosis drugs (AODs) are increasing for the elderly and for postmenopausal women. We investigate the secular trends of AODs in South Korea. @*Methods@#We used the Intercontinental Medical Statistics Health Sales Audit between January 1, 2006 and December 31, 2018. We analyzed the total sales costs and market share of AODs including bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), calcitonins, and denosumab using the number of days of therapy (DOT). Changes of prescription patterns including original versus generic drugs, vitamin D combination, and types of medical institutions were also analyzed. @*Results@#Bisphosphonates were the most frequently used drug during the study period although its DOT declined from 92.5% in 2008 to 80.0% in 2018. SERMs were the second-most used medication, and has maintained around 13% since 2015. The proportion of calcitonins has decreased since 2011, mainly due to malignancy risk. In contrast, the DOT of PTH and denosumab increased to 0.8% and 4.7% in 2018, respectively. The use of generics, vitamin D combination, and intravenous bisphosphonates has been increasing throughout the study period. @*Conclusions@#Prescription patterns using DOT are changing probably due to the increase in older adult patients and severely osteoporotic patients. There are other issues including safety and the launching of new drugs.

Reference Ranges of Serum Insulin-Like Growth Factor-I and Insulin-Like Growth Factor Binding Protein-3: Results from a Multicenter Study in Healthy Korean Adults

Insulin-like growth factor-I (IGF-I) plays a pivotal role in the diagnosis and treatment of growth hormone (GH) excess or deficiency. The GH study group of the Korean Endocrine Society aims to establish the Korean reference ranges of serum IGF-I and insulin-like growth factor binding protein-3 (IGFBP-3) and assess the relationship between IGF-I and IGFBP-3 and clinical parameters. Fasting serum was collected from healthy Korean adults at health promotion centers of five hospitals nationwide. Serum IGF-I and IGFBP-3 were measured via an immunoradiometric assay using a DSL kit (Diagnostic Systems Laboratories). Serum samples from 354 subjects (180 male, 174 female) were analyzed based on sex at 10-year intervals from 21 to 70 years. IGF-I levels were inversely correlated with age. After adjustment of age, the IGF-I/IGFBP-3 ratio was significantly negatively associated with blood pressure and free thyroxine and positively associated with weight, hemoglobin, creatinine, alanine transferase, fasting glucose, and thyroid stimulating hormone. Therefore, age- and sex-specific reference ranges of serum IGF-I and IGFBP-3 can be efficient in evaluating GH excess or deficiency in Korean population.

The secular trends in the use of medications for osteoporosis in South Korea using Intercontinental Medical Statistics Health Sales Audit 2006-2018

Objectives@#Osteoporosis medications are widely available in South Korea, and well reimbursed by the Government Health Insurance; however, some expensive drugs are not reimbursed. The prescription of anti-osteoporosis drugs (AODs) are increasing for the elderly and for postmenopausal women. We investigate the secular trends of AODs in South Korea. @*Methods@#We used the Intercontinental Medical Statistics Health Sales Audit between January 1, 2006 and December 31, 2018. We analyzed the total sales costs and market share of AODs including bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), calcitonins, and denosumab using the number of days of therapy (DOT). Changes of prescription patterns including original versus generic drugs, vitamin D combination, and types of medical institutions were also analyzed. @*Results@#Bisphosphonates were the most frequently used drug during the study period although its DOT declined from 92.5% in 2008 to 80.0% in 2018. SERMs were the second-most used medication, and has maintained around 13% since 2015. The proportion of calcitonins has decreased since 2011, mainly due to malignancy risk. In contrast, the DOT of PTH and denosumab increased to 0.8% and 4.7% in 2018, respectively. The use of generics, vitamin D combination, and intravenous bisphosphonates has been increasing throughout the study period. @*Conclusions@#Prescription patterns using DOT are changing probably due to the increase in older adult patients and severely osteoporotic patients. There are other issues including safety and the launching of new drugs.

Reference Ranges of Serum Insulin-Like Growth Factor-I and Insulin-Like Growth Factor Binding Protein-3: Results from a Multicenter Study in Healthy Korean Adults

Insulin-like growth factor-I (IGF-I) plays a pivotal role in the diagnosis and treatment of growth hormone (GH) excess or deficiency. The GH study group of the Korean Endocrine Society aims to establish the Korean reference ranges of serum IGF-I and insulin-like growth factor binding protein-3 (IGFBP-3) and assess the relationship between IGF-I and IGFBP-3 and clinical parameters. Fasting serum was collected from healthy Korean adults at health promotion centers of five hospitals nationwide. Serum IGF-I and IGFBP-3 were measured via an immunoradiometric assay using a DSL kit (Diagnostic Systems Laboratories). Serum samples from 354 subjects (180 male, 174 female) were analyzed based on sex at 10-year intervals from 21 to 70 years. IGF-I levels were inversely correlated with age. After adjustment of age, the IGF-I/IGFBP-3 ratio was significantly negatively associated with blood pressure and free thyroxine and positively associated with weight, hemoglobin, creatinine, alanine transferase, fasting glucose, and thyroid stimulating hormone. Therefore, age- and sex-specific reference ranges of serum IGF-I and IGFBP-3 can be efficient in evaluating GH excess or deficiency in Korean population.

Do basic psychological needs affect student engagement in medical school? / 한국의학교육

PURPOSE: The purpose of this study is to verify the effect of basic psychological needs of learners on student engagement in medical school. METHODS: A total of 91 first-year and second-year medical students participated in this study. Their basic psychological needs were determined. Student engagement scales were utilized to determine their engagement. Correlation and multiple regression analyses were conducted. RESULTS: Basic psychological needs showed a total explanatory power of 13% for student engagement (F=5.27, p < 0.01). Competence (β=0.295, p < 0.01) had statistically significant effect on student engagement. CONCLUSION: Results of the present study verified that student engagement could be determined by learner's traits. Among psychological traits of learners, student engagement was significantly affected by competence. Thus, medical school should provide various experiences to satisfy competence as a basic psychological need of learners.

An updated hip fracture projection in Asia: The Asian Federation of Osteoporosis Societies study

OBJECTIVES: Hip fracture is a major public health problem. Earlier studies projected that the total number of hip fracture will increase dramatically by 2050, and most of the hip fracture will occur in Asia. To date, only a few studies provided the updated projection, and none of them focused on the hip fracture projection in Asia. Thus, it is essential to provide the most up to date prediction of hip fracture in Asia, and to evaluate the total direct medical cost of hip fracture in Asia. METHODS: We provide the updated projection of hip fracture in 9 Asian Federation of Osteoporosis Societies members using the most updated incidence rate and projected population size. RESULTS: We show that the number of hip fracture will increase from 1,124,060 in 2018 to 2,563,488 in 2050, a 2.28-fold increase. This increase is mainly due to the changes on the population demographics, especially in China and India, which have the largest population size. The direct cost of hip fracture will increase from 9.5 billion United State dollar (USD) in 2018 to 15 billion USD in 2050, resulting a 1.59-fold increase. A 2%–3% decrease in incidence rate of hip fracture annually is required to keep the total number of hip fracture constant over time. CONCLUSIONS: The results show that hip fracture remains a key public health issue in Asia, despite the available of better diagnosis, treatment, and prevention of fracture over the recent years. Healthcare policy in Asia should be aimed to reduce the burden of hip fracture.

The mediating effect of calling on the relationship between medical school students' academic burnout and empathy / 한국의학교육

PURPOSE: This study is aimed at identifying the relationships between medical school students' academic burnout, empathy, and calling, and determining whether their calling has a mediating effect on the relationship between academic burnout and empathy. METHODS: A mixed method study was conducted. One hundred twenty-seven medical students completed a survey. Scales measuring academic burnout, medical students’ empathy, and calling were utilized. For statistical analysis, correlation analysis, descriptive statistics analysis, and hierarchical multiple regression analyses were conducted. For qualitative approach, eight medical students participated in a focus group interview. RESULTS: The study found that empathy has a statistically significant, negative correlation with academic burnout, while having a significant, positive correlation with calling. Sense of calling proved to be an effective mediator of the relationship between academic burnout and empathy. CONCLUSION: This result demonstrates that calling is a key variable that mediates the relationship between medical students' academic burnout and empathy. As such, this study provides baseline data for an education that could improve medical students' empathy skills.

Potential bias factors that affect the course evaluation of students in preclinical courses / 한국의학교육

PURPOSE: We aim to identify what potential bias factors affected students' overall course evaluation, and to observe what factors should be considered in the curriculum evaluation system of medical schools. METHODS: This study analyzed students' ratings of preclinical instructions at the Ajou University School of Medicine. The ratings of instructions involved 41 first-year and 45 second-year medical students. RESULTS: There was a statistically significant difference between years of study and ratings' scoring. Learning difficulty, learning amount, student assessment, and teacher preparation from second-year students were significantly higher than first-year students (p<0.05). The analysis results revealed that student assessment was the predictor of ratings from first-year students, while teacher preparation was the predictor of ratings from second-year students. CONCLUSION: We found significant interactions between year of study and the students' rating results. We were able to confirm that satisfaction of instructions factors perceived by medical students were different for the characteristics of courses. Our results may be an important resource for evaluating preclinical curriculums.

Effects of Single Vitamin D₃ Injection (200,000 Units) on Serum Fibroblast Growth Factor 23 and Sclerostin Levels in Subjects with Vitamin D Deficiency

BACKGROUND: Vitamin D deficiency remains common in all age groups and affects skeletal and non-skeletal health. Fibroblast growth factor 23 is a bone-derived hormone that regulates phosphate and 1,25-dihydroxyvitamin D homeostasis as a counter regulatory factor. 1,25-Dihydroxyvitamin D stimulates fibroblast growth factor 23 synthesis in bone, while fibroblast growth factor 23 suppresses 1,25-dihydroxyvitamin D production in the kidney. The aim of this study was to evaluate the effects of vitamin D₃ intramuscular injection therapy on serum fibroblast growth factor 23 concentrations, and several other parameters associated with bone metabolism such as sclerostin, dickkopf-1, and parathyroid hormone. METHODS: A total of 34 subjects with vitamin D deficiency (defined by serum 25-hydroxyvitamin D levels below 20 ng/mL) were randomly assigned to either the vitamin D injection group (200,000 units) or placebo treatment group. Serum calcium, phosphate, urine calcium/creatinine, serum 25-hydroxyvitamin D, fibroblast growth factor 23, sclerostin, parathyroid hormone, and dickkopf-1 levels were serially measured after treatment. RESULTS: Comparing the vitamin D injection group with the placebo group, no significant changes were observed in serum fibroblast growth factor 23, parathyroid hormone, or dickkopf-1 levels. Serum sclerostin concentrations transiently increased at week 4 in the vitamin D group. However, these elevated levels declined later and there were no statistically significant differences as compared with baseline levels. CONCLUSION: Serum fibroblast factor 23, sclerostin, parathyroid hormone, and dickkopf-1 levels were not affected significantly by single intramuscular injection of vitamin D₃.

Efficacy and safety of vitamin D3 B.O.N intramuscular injection in Korean adults with vitamin D deficiency

OBJECTIVE: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin D3 after intramuscular injection in Korean adults with vitamin D deficiency. METHODS: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ≥19 and <65 years of age were randomly allocated to either the vitamin D3 or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin D3 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mL on week 12 or thereafter, a repeat injection was administered. RESULTS: After a single intramuscular injection of vitamin D3 to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ≥30 ng/mL within 12 weeks was 46.4% in the vitamin D3 group and 3.6% in the placebo group (p < 0.0001). The proportion of subjects with serum 25(OH)D concentrations ≥30 ng/mL within 24 weeks was 73.2% in the vitamin D3 group and 3.6% in the placebo group (p < 0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin D3 injection was 12.8 ± 8.1 and 21.5 ± 8.1 ng/mL, respectively, in the vitamin D3 group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin D3 group but no change in the placebo group. CONCLUSION: Intramuscular injection of vitamin D3 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

Sarcopenia and Sarcopenic Obesity in Patients Undergoing Orthopedic Surgery

BACKGROUND: The purpose of this retrospective study was to determine the prevalence of sarcopenia and sarcopenic obesity among patients who underwent orthopedic surgery (OS). METHODS: A total of 222 patients were reviewed immediately after or prior to OS. In the control group, 364 patients from outpatient departments (OPDs) who did not have any OS were enrolled. Whole-body dual-energy X-ray absorptiometry was used to analyze body composition. Skeletal muscle mass was adjusted for height squared, total body weight, and height and fat mass (residuals). Obesity was defined as body mass index (BMI) > 25.0 kg/m2. RESULTS: The prevalence of sarcopenia in the OS group was 25.7%, 44.1%, and 26.6%, respectively, according to the 3 different criteria. The prevalence was significantly lower in the OPD group (6.0%, 33.1%, and 14.8%, respectively). The highest rates of sarcopenia with height-adjusted definition were seen in patients with a femoral neck fracture. In the multivariate analysis, factors associated with sarcopenia were male gender, older age, and lower BMI (odds ratio [OR]: 28.38, 1.03, and 1.83, respectively) when muscle mass was adjusted for height, whereas male gender, older age, and higher BMI were associated with sarcopenia (OR: 1.04, 2.57, and 1.83, respectively) when adjusted for weight. When residuals were used as a cutoff, decreased BMI and total hip bone mineral density (0.1 g/cm2) were independent risk factors associated with sarcopenia (OR: 1.09 and 1.05). The prevalence of sarcopenic obesity ranged from 1.8% to 21.2%. CONCLUSIONS: Our study demonstrated a high prevalence of sarcopenia among OS patients.

Sarcopenia and Sarcopenic Obesity in Patients Undergoing Orthopedic Surgery

BACKGROUND: The purpose of this retrospective study was to determine the prevalence of sarcopenia and sarcopenic obesity among patients who underwent orthopedic surgery (OS). METHODS: A total of 222 patients were reviewed immediately after or prior to OS. In the control group, 364 patients from outpatient departments (OPDs) who did not have any OS were enrolled. Whole-body dual-energy X-ray absorptiometry was used to analyze body composition. Skeletal muscle mass was adjusted for height squared, total body weight, and height and fat mass (residuals). Obesity was defined as body mass index (BMI) > 25.0 kg/m2. RESULTS: The prevalence of sarcopenia in the OS group was 25.7%, 44.1%, and 26.6%, respectively, according to the 3 different criteria. The prevalence was significantly lower in the OPD group (6.0%, 33.1%, and 14.8%, respectively). The highest rates of sarcopenia with height-adjusted definition were seen in patients with a femoral neck fracture. In the multivariate analysis, factors associated with sarcopenia were male gender, older age, and lower BMI (odds ratio [OR]: 28.38, 1.03, and 1.83, respectively) when muscle mass was adjusted for height, whereas male gender, older age, and higher BMI were associated with sarcopenia (OR: 1.04, 2.57, and 1.83, respectively) when adjusted for weight. When residuals were used as a cutoff, decreased BMI and total hip bone mineral density (0.1 g/cm2) were independent risk factors associated with sarcopenia (OR: 1.09 and 1.05). The prevalence of sarcopenic obesity ranged from 1.8% to 21.2%. CONCLUSIONS: Our study demonstrated a high prevalence of sarcopenia among OS patients.

Changes in bone mineral density and trabecular bone score in Graves' disease patients after anti-thyroid therapy

OBJECTIVE: The purpose of this study was to evaluate changes in bone quantity based on bone mineral density (BMD) and bone quality based on trabecular bone score (TBS) in Graves' disease patients after anti-thyroid therapy. RESEARCH DESIGN AND METHOD: This retrospective study included premenopausal female and male patients with Graves' disease who received BMD measurement more than two times during treatment. BMD and thyroid function tests with free thyroxine (FT4), total triiodothyronine (T3), thyroid stimulating hormone (TSH), and TSH receptor antibody (TRAb) levels were collected two times during follow-up. TBS was calculated using TBS insight® software (version 2.1) from dual-energy X-ray absorptiometry images. RESULTS: Thirty Graves' disease patients (17 males, 56%; 13 premenopausal females, 44%) with a mean age of 35.3 ± 9.9 years were included. The mean follow-up period was 20.7 ± 8.5 months. The median levels of FT4, TSH and TRAb improved at follow-up [2.55 ng/dL (Interquartile range (IQR) 2.07-3.78) to 1.28 ng/dL (IQR 1.23-1.39), 0.015 mIU/L (IQR 0.01-0.04) to 0.89 mIU/L (IQR 0.35-1.55), 17.0 IU/L (IQR 5.0-40.3) to 5.0 IU/L (5.0-6.0), respectively; p < 0.001]. Median BMD (lumbar spine) values also improved from 1.118 g/cm² (IQR 1.000-1.119) to 1.167 g/cm² (IQR 1.050-1.219) ( p = 0.001) at follow-up. TBS increased from 1.377 (IQR 1.299-1.422) to 1.390 (IQR 1.327-1.430) after treatment ( p = 0.038). CONCLUSIONS: Both bone quality and density improved after anti-thyroid treatment in premenopausal female and male Graves' disease patients.

Medical treatment of severe osteoporosis including new concept of advanced severe osteoporosis

Osteoporosis is a metabolic bone disease characterized by decreased bone strength, leading to an increased risk of fracture. The World Health Organization (WHO) defines osteoporosis as a bone mineral density (BMD) of 2.5 standard deviations below that of a young adults (T-score of -2.5 or lower). Severe osteoporosis is differentiated from osteoporosis by the presence of one or more fragility fractures in addition to this T-score. However, the current WHO definition may be insufficient to reflect the diverse spectrum of osteoporosis or severe osteoporosis, which can encompass various number and severity of prevalent fractures. To overcome these shortcomings of the WHO definition of osteoporosis, we propose a concept of 'advanced severe osteoporosis', which is defined by the presence of proximal femur fragility fracture or two or more fragility fractures in addition to BMD T-score of -2.5 or less. Based on the previous clinical trials and post-hoc analyses, we recommend selective estrogen receptor modulators, bisphosphonates, receptor activator of nuclear factor kappa-B ligand (RANKL) monoclonal antibody, and parathyroid hormone for the medical treatment of severe osteoporosis. In cases of advanced severe osteoporosis or osteoporosis that does not respond to previous anti-osteoporotic treatments, we also recommend parathyroid hormone, bisphosphonates, and RANKL monoclonal antibody. In conclusion, we need more precise assessment of osteoporosis and further stratification of the disease by number of prevalent fractures in addition to BMD. More aggressive managements should be provided for those with advanced severe osteoporosis.

Type 2 diabetes mellitus and bone fragility: Special focus on bone imaging

Fragility fracture rate is increased in type 2 diabetes patients despite of higher bone mineral density than non-diabetes control subjects. Vertebral fractures are usually asymptomatic; therefore, morphometric radiologic evaluation should be considered especially for diabetes patients. Bone quality may more contribute to the increased risk of osteoporotic fractures in patients with type 2 diabetes than bone mass. Hip geometry, cortical porosity, and trabecular bone score have been studied as bone quality parameters by imaging in type 2 diabetes mellitus.

Perception of severe osteoporosis amongst medical doctors in South Korea: Awareness, impact, and treatment

OBJECTIVES: Little is currently known about the issues surrounding management and treatment of severe osteoporosis in South Korea. Our objective was to assess doctors' views on the perception, diagnosis, and treatment of severe osteoporosis. METHODS: Face-to-face interviews were conducted (16 February-13 March 2015) with 100 doctors (specialists in orthopedic surgery, endocrinology, neurosurgery, family medicine, or rheumatology) who treated ≥5 severe osteoporosis (T-score ≤ -2.5, plus fracture) patients per month. Respondent demographic characteristics, their perception of severe osteoporosis, its impact and treatment, and their views on current practice and unmet needs were assessed. RESULTS: Of 416 doctors approached, 100 completed the survey (24% response rate). Most doctors (90%) specialized in orthopedic surgery, endocrinology, or neurosurgery. When diagnosing severe osteoporosis, most doctors (79%) considered both bone mineral density and fracture. Almost all doctors (≥91%) ranked disease impact and seriousness highly, but much fewer (≤25%) doctors thought society agreed. Most doctors (89%) had concerns with current treatments, switching treatments because of the efficacy and safety of bisphosphonates (>89%), the efficacy of selective estrogen receptor modulators (>71%), and the high cost of parathyroid hormone (>73%). Parathyroid hormone was ranked highest for efficacy and was preferentially prescribed to severe osteoporosis patients (mean 32.2% of prescriptions) compared with osteoporosis patients overall (3.7%). "Limitations with reimbursement" was the most commonly cited (76%) unmet need. CONCLUSIONS: There are concerns with the safety, efficacy, and affordability of current treatments for severe osteoporosis in South Korea, as well as a perceived lack of disease awareness amongst patients and doctors.

Obesity and Hyperglycemia in Korean Men with Klinefelter Syndrome: The Korean Endocrine Society Registry

BACKGROUND: The aim of this study was to investigate the prevalence of obesity in Korean men with Klinefelter syndrome (KS) and the associated risk factors for obesity and hyperglycemia. METHODS: Data were collected retrospectively from medical records from 11 university hospitals in Korea between 1994 and 2014. Subjects aged ≥18 years with newly diagnosed KS were enrolled. The following parameters were recorded at baseline before treatment: chief complaint, height, weight, fasting glucose level, lipid panel, blood pressure, testosterone, luteinizing hormone, follicle-stimulating hormone, karyotyping patterns, and history of hypertension, diabetes, and dyslipidemia. RESULTS: Data were analyzed from 376 of 544 initially enrolled patients. The rate of the 47 XXY chromosomal pattern was 94.1%. The prevalence of obesity (body mass index ≥25 kg/m²) in Korean men with KS was 42.6%. The testosterone level was an independent risk factor for obesity and hyperglycemia. CONCLUSION: Obesity is common in Korean men with KS. Hypogonadism in patients with KS was associated with obesity and hyperglycemia.

Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension

PURPOSE: The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. MATERIALS AND METHODS: Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg. RESULTS: Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints (mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvements were sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals. CONCLUSION: Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effects on the measures of osteoporosis in Korean postmenopausal women.