Patient Perception on Osteoporosis in Korean Female Patients with Osteoporosis.

BACKGROUND: Patient perception is a key element in improving compliance with medications for osteoporosis. This study evaluated the awareness, perception, sources of information, and knowledge of osteoporosis among Korean women with osteoporosis. METHODS: A questionnaire survey was conducted from July 22, 2021 to 13 August 2021. Patients who were followed up in endocrinology (Endo), orthopedic surgery (OS), and gynecology (GY) were recruited (N=40, 40, and 20 in each group). Patients were allocated according to their age, as follows: 15, 15, and 10 patients in their 60s, 70s, and 80s for Endo and OS, and 10 and 10 patients in their 60s and 70s for GY. The questionnaire was composed of the following topics: patient journey to the hospital, drug-related issues, communication with medical doctors, patient knowledge, and sources of information about osteoporosis. RESULTS: The results of medical check-ups were the most common reason for patient visits to the hospital for an initial diagnosis of osteoporosis (61%). A knowledge gap regarding mortality, refracture, and drug-induced osteoporosis was observed. Doctors were the most preferred and trustful source of information, while health-related TV shows were the second most common source of information. Patients with OS reported lower perceived severity and higher drug discontinuation, along with a higher proportion of fractures, as the initial reasons for hospital visits for osteoporosis. CONCLUSIONS: Variations in perceptions according to the issue and group were identified. These should be considered during patient consultations to improve compliance with osteoporosis treatment.

Effects of Bazedoxifene/Vitamin D Combination Therapy on Serum Vitamin D Levels and Bone Turnover Markers in Postmenopausal Women with Osteopenia: A Randomized Controlled Trial.

BACKGROUND: This study aimed to evaluate the effectiveness of bazedoxifene/vitamin D combination therapy in preventing osteoporosis in postmenopausal women with osteopenia. METHODS: This was an open-label, multicenter randomized-controlled, phase 4 clinical trial. Women between ages of 55 and 70 years in 9 medical tertiary centers in Korea were enrolled and assigned into 2 groups: an experiment group and a control group. The experimental group received bazedoxifene 20 mg/vitamin D 800 IU tablets for 6 months, and the control group received calcium 100 mg/vitamin D 1,000 IU tablets for 6 months. RESULTS: A total of 142 patients (70 in the experimental group and 72 in the control group) were included. The least-square mean±standard error of change in propeptide of type I collagen after 3 months was -6.87±2.56% in the experimental group and 1.22±2.54% in the control group. After 6 months, it was -21.07±2.75% in the experimental group and 1.26±2.71% in the control group. The difference between the 2 groups was -22.33% (p<0.01). The change of C-terminal telopeptide was -12.55±4.05% in the experimental group and 11.02±4.03% in the control group after 3 months. It was -22.0±3.95% and 10.20±3.89, respectively, after 6 months. The difference between the 2 groups was -32.21% (p<0.01) after 6 months. There was no significant difference in adverse events between the 2 groups. CONCLUSIONS: The osteoporosis preventive effect and safety of administering bazedoxifene/vitamin D combination pill were confirmed in postmenopausal women who needed osteoporosis prevention.

Raloxifene/Vitamin D Combination Therapy vs. Raloxifene Monotherapy on Serum 25-Hydroxy-Vitamin D Level among Postmenopausal Women with Osteoporosis or Osteopenia: A Randomized Controlled Trial.

BACKGROUND: We compared the efficacy of a fixed dose combination of raloxifene 60 mg/vitamin D 800 IU to raloxifene 60 mg alone on vitamin D status, as indicated by change in serum 25-hydroxy-vitamin D (25[OH]D) levels. METHODS: In this 16-week, open-label, randomized, active controlled, multicenter clinical trial conducted in 4 university-affiliated hospitals in Korea, postmenopausal women aged 55 to 70 years with osteoporosis or osteopenia were randomly assigned in a 1:1 ratio to receive raloxifene 60 mg/cholecalciferol 800 IU combination therapy or raloxifene 60 mg monotherapy. Primary endpoint was change in serum 25(OH)D level from baseline to 16 weeks after the intervention. RESULTS: A total of 96 participants were randomly assigned to raloxifene/vitamin D combination therapy (N=49) and raloxifene monotherapy (N=47) groups. At week 16, serum 25(OH)D level increased from baseline, only in the raloxifene/vitamin D combination therapy group. Change in serum 25(OH)D level from baseline to week 16 was higher in the raloxifene/vitamin D combination therapy group (2.7±6.5 ng/mL) than in the raloxifene monotherapy (-1.7±6.2 ng/mL; P=0.0034) group. Proportions and number of adverse events (AEs) categorized by the System-Organ Class were not different between the groups. There was only one severe AE case (spondylolisthesis; raloxifene/vitamin D group), unlikely to be related to trial intervention. CONCLUSIONS: Among postmenopausal women with osteoporosis or osteopenia, a fixed dose combination of raloxifene 60 mg/vitamin D 800 IU showed superior efficacy in elevating serum 25(OH)D levels compared with raloxifene 60 mg alone during 16 weeks of follow-up. The safety of raloxifene/vitamin D combination was comparable to raloxifene alone.

Impact on Bisphosphonate Persistence and Compliance: Daily Postprandial Administration.

BACKGROUND: Bisphosphonate (BP) is an effective drug for the prevention and treatment of osteoporosis. However, gastrointestinal distress caused by BP is a well-known side effect for low compliance. The aim of our study was to compare the 1-year persistence, compliance and T-scores between the aperitif medication group and the postprandial medication group. METHODS: Three hundred patients were included in this study to determine their persistence and compliance with the prescribed daily BP (Maxmarvil®, alendronate 5 mg and calcitriol 0.5 µg; YuYu Pharm) following distal radius fractures. Patients in Group 1 (aperitif medication) were asked to adhere to the general guidelines for BPs before breakfast. Patients in Group 2 (postprandial medication) were recommended medication after breakfast. We compared the persistence and compliance of this daily BP therapy using the medication possession ratio (MPR) and T-scores between the 2 groups after 1 year. RESULTS: Bone mineral density in hip and lumbar spine was improved significantly in 2 groups (P<0.001). Significant differences existed between 2 groups, including 73 of 150 patients (48.7%) in Group 1, and 111 of 150 patients (73.3%) in Group 2 for 1-year persistence (P=0.001). The mean MPR is 0.66 in Group 1 (range, 0.50-0.86) and 0.71 in Group 2 (range, 0.54-0.87). A significant difference was detected between the 2 groups (P=0.002). CONCLUSIONS: Postprandial administration improved persistence and compliance with daily BP therapy, resulting in better clinical outcomes.

Association between Sarcopenia, Sarcopenic Obesity, and Chronic Disease in Korean Elderly.

BACKGROUND: It is a very important social issue for Korea to have a healthy old age as an aged society. Aging causes a lot of physical changes, especially sarcopenia. Sarcopenia is defined as a persistent decrease in skeletal muscle and muscle strength. Sarcopenic obesity is a phenomenon in which fat is replaced instead of muscle. The purpose of this study was to examine the prevalence of sarcopenia and sarcopenic obesity in Korean elderly and to analyze the relationship with chronic disease. METHODS: Data from the 2008 to 2011 the Korea National Health and Nutrition Survey were used. A total of 3,492 patients were classified into 3 groups (non-sarcopenia, sarcopenia, sarcopenic obesity), and general, anthropometry, health behavior, nutrient intake and chronic disease status were compared by the statistical analysis. RESULTS: The rate of moderate exercise was significantly lower in the sarcopenia and sarcopenic-obesity group than in the non-sarcopenia group (P=0.007). The sarcopenic obesity group had significantly higher energy (P=0.005), protein (P=0.046) and fat (P=0.001) intake than the sarcopenic group. The sarcopenic-obesity group had the highest ratio of diabetes (P=0.023) and dyslipidemia (P=0.004) in the 3 groups. Compared with the non-sarcopenia group, in the sarcopenia and sarcopenic obesity groups, the odds ratios (ORs) of diabetes was increased by 1.24 and 2.16 while the ORs of dyslipidemia was increased by 1.12 and 1.50, respectively. CONCLUSIONS: Regular exercise and adequate nutrient intake (energy, protein and fat) are essential for the prevention of sarcopenia in Korean elderly, and management of chronic disease in sarcopenic obesity elderly is important.

Serum Vitamin D Level Related to Coffee Consumption in Korean Young Adults Using the 5th Korea National Health and Nutrition Examination Survey.

BACKGROUND: Even young adults are highly interested in their osteological health, yet their calcium intake does not match the level of such interest. Increase in bone loss is known to be associated with higher intake of caffeine and coffee consumption among the young Korean is rising steadily. This study was conducted to reveal the relationship between coffee consumption and serum vitamin D level in Korean young adults. METHODS: This study analyzed potential difference in lifestyle and concentration of vitamin D in blood in relation to coffee intake frequency of 2,523 subjects on the basis of data from the 5th Korea National Health and Nutrition Examination Survey. RESULTS: According to the analysis, groups of males, with high income, frequent social activity followed by alcohol consumption and smoking, and high rate of dining out showed a high frequency of coffee consumption. Vitamin D concentration among the groups was 16.2±5.3 mL and 80.3% of them were considered to be vitamin D-deficient. All the groups appeared to have deficiencies compared to males who did not consume caffeine at all. CONCLUSIONS: The practice of having an adequate amount of coffee is needed, and more efforts should be done to improve vitamin D intake among young adults.

Low calcium and vitamin D intake in Korean women over 50 years of age.

Inadequate calcium and vitamin D intake is a possible risk factor of osteoporosis. Our purposes were to estimate calcium and vitamin D intake in Korean women, and to determine associated risk factors for low calcium and vitamin D intake. This is a multicenter, hospital-based, and cross-sectional study on osteoporosis. In this study, 1516 women of 50 years or older were involved. Dietary calcium and vitamin D intake were evaluated using the self-reporting KCAT questionnaire. Average daily calcium intake was 662.8 ± 473.8 mg, and vitamin D intake 9.5 ± 10.7 µg. In multivariate analysis, older age (OR 1.02, 95 % CI 1.00-1.04, p = 0.001), and rural residence (OR 2.43, 95 % CI 1.34-4.43, p = 0.004) were significant risk factors for lower calcium intake, and older age (OR 1.03, 95 % CI 1.02-1.04, p < 0.001), and rural residence (OR 1.85, 95 % CI 1.10-3.11, p < 0.001) were significant risk factors for lower vitamin D intake. About 70 % of women aged 50 years or older had calcium and vitamin D intake below the recommended dietary intake. Older age and rural residence were significant risk factors for lower calcium and vitamin D intake in Korean women.

Position Statement: Drug Holiday in Osteoporosis Treatment with Bisphosphonates in South Korea.

Bisphosphonates have been widely used in the treatment of osteoporosis with robust data from many placebo-controlled trials demonstrating its efficacy in fracture risk reduction over 3 to 5 years of treatment. Although bisphosphonates are generally safe and well tolerated, concerns have emerged about the adverse effects related to its long-term use, including osteonecrosis of the jaw and atypical femur fractures. Because bisphosphonates are incorporated into the skeleton and continue to exert an anti-resorptive effect for a period of time after the discontinuation of drugs, the concept of a "drug holiday" has emerged, whereby the risk of adverse effects might be decreased while the patient still benefits from anti-fracture efficacy. As randomized clinical trial evidence is not yet available on who may qualify for a drug holiday, there is considerable controversy regarding the selection of candidates for the drug holiday and monitoring during a drug holiday, both of which should be based on individual assessments of risk and benefit. This statement will provide suggestions for clinicians in South Korea on the identification of possible candidates and monitoring during a bisphosphonate drug holiday.

Efficacy and safety of weekly alendronate plus vitamin D3 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial.

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D3 (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.

Endoscopic comparison of alendronate alone and the enteric-coated alendronate with calcitriol combination in postmenopausal Korean females.

BACKGROUND/AIMS: This study was performed to compare the mucosal findings after esophagogastroduodenoscopy in two groups before and after the use of alendronate only and following administration of the enteric-coated alendronate (5 mg) and calcitriol (0.5 µg) combined drug (Maxmarvil, Yuyu Co.). METHODS: The study population consisted of 33 postmenopausal healthy female volunteers, aged 50 to 70 years (mean age, 58 ± 5) without gastrointestinal symptoms and with normal baseline endoscopic findings. Esophagogastroduodenoscopy was performed at baseline and was repeated 2 weeks later after daily intake of Maxmarvil (n = 17 subjects) or alendronate only (n = 16 subjects). Mucosal injury scores were reported by an endoscopist after 2 weeks of treatment with each medication schedule. RESULTS: Esophageal mucosal injuries developed in two of 16 subjects in the alendronate only group and 0 of 17 in the Maxmarvil group. Gastric mucosal injuries developed in eight subjects in the alendronate group and four subjects in the Maxmarvil group; this difference was statistically significant. CONCLUSIONS: The mucosal damage scores for the alendronate group (total score 24) were significantly higher than those for the Maxmarvil group (total score 9) in the esophagus and stomach. Therefore, this study suggested that enteric-coated Maxmarvil is less harmful to gastrointestinal mucosa than alendronate, and may improve the tolerability of osteoporosis medication in clinical practice.

Domestic Characteristics and Trends of Publications on Bone Metabolism in South Korea between 1998 and 2012.

BACKGROUND: This study was undertaken to investigate the trends in domestic publications on bone metabolism during the last decade, and to document the characteristics of articles in South Korea. METHODS: Articles on bone metabolism including osteoporosis published between 1998 and 2012 were evaluated, in terms of title, type of articles, subspecialty, and authors' affiliations. We used descriptive statistics for presenting the characteristics of domestic publication on bone metabolism. RESULTS: Total of 247 articles, published articles between 1998 and 2012, were reviewed. Over a total study period of 14 years, the number of articles which was initially 109 in the first half term increased to 247 during the period of second half. Of these 247 articles, 52 were on basic research, and 195 were on clinical research. Although the types of article were added in the later 7 years were much diverse than that of the earlier 7 years, the proportion of original articles has decreased. CONCLUSIONS: Our findings presented the characteristics and trends of domestic publication on bone metabolism in South Korea, and concerns for editorial boards in future.

Positive correlation between erythrocyte levels of n-3 polyunsaturated fatty acids and bone mass in postmenopausal Korean women with osteoporosis.

BACKGROUND: Osteoporosis, a major health problem among postmenopausal women, is influenced by dietary factors. The purpose of the present study was to evaluate the hypothesis that erythrocyte levels of n-3 polyunsaturated fatty acid (PUFA) and the dietary intake of fish are associated with risk of osteoporosis and correlate with bone mass in postmenopausal Korean women with the disease. METHODS: Fifty cases and 100 controls were recruited. Osteoporosis was defined according to the International Society for Clinical Densitometry guideline as a score lower than -2.5 SD below the T-score for lumbar vertebrae L1-L4, femoral neck or femoral total. RESULTS: The T-score of the femoral neck was positively correlated with erythrocyte levels of n-3 PUFA, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and the intake of fish, and was negatively correlated with the ratio of n-6/n-3 PUFA after adjusting for age, years after menopause and height. In addition, the risk of osteoporosis was positively associated with erythrocyte levels of saturated fatty acids but negatively associated with EPA + DHA. CONCLUSIONS: Erythrocyte levels of n-3 PUFA and the intake of fish were positively correlated with bone mass. In particular, erythrocyte levels of EPA + DHA reduced the risk of osteoporosis in postmenopausal Korean women.

Regulation of glucose control in people with type 2 diabetes: a review and consensus.

A conference was convened by the Korean Diabetes Association and the Korean Endocrine Society on September 7, 2009 to discuss and organize the results of research on intensive glucose control for the prevention of cardiovascular disease in patients with type 2 diabetes. Professor Kyung Soo Park led the conference, and Professors Kwang Won Kim and Ho Young Son acted as chairmen. Professors Doo Man Kim, Tae Sun Park, and Bong Soo Cha reported on intensive glucose control and diabetic complications, including the UK Prospective Diabetes Study (UKPDS), Diabetes Control and Complication Trial (DCCT) research results, the recently published Action to Control Cardiovascular Risk in Diabetes (ACCORD), Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE), and Veterans Affairs Diabetes Trial (VADT) research, as well as meta-analyses. Professor Jeong-Taek Woo reported on the manuscript written by the committee for the Korean Diabetes Association which dealt with the treatment of diabetes mellitus. Professors Kyung Soo Ko, Joong Yeol Park, Hyun Shik Son, Moon-Kyu Lee, Dong-Won Byun, and Yoon-Sok Chung participated in the discussion and collected information for the manuscript from all of the participants. The aim of the debate was to determine how to establish target goals for intensive glucose control and how to individualize those goals. The participants concluded that there was no need to modify the recommendation of maintaining an HbA1c under 6.5%, the current blood glucose treatment goal that is recommended by the Korean Diabetes Association. In addition, individual target goals for glucose control were recommended depending on the situation of each patient. We report on the consensus statement from the meeting.

Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women.

Patient preferences, convenience, and bone turnover markers were evaluated for the monthly ibandronate over the weekly risedronate regimen in Korean postmenopausal osteoporotic women. This was a 6-month, prospective, randomized, open-label, multicenter study with a two-period and two-sequence crossover treatment design. After a 30-day screening period, eligible participants with postmenopausal osteoporosis were randomized to receive either monthly oral ibandronate 150 mg for 3 months followed by weekly oral risedronate 35 mg for 12 weeks (sequence A) or the same regimen in reverse order (sequence B). Patient preference and convenience were evaluated by questionnaire. The changes in serum C-telopeptide after 3 months of treatment were analyzed. A total of 365 patients were enrolled in this study (sequence A 182, sequence B 183). Of patients expressing a preference (83.4%), 74.8% preferred the monthly ibandronate regimen over the weekly regimen (25.2%). More women stated that the monthly ibandronate regimen was more convenient (84.2%) than the weekly regimen (15.8%). There was no significant difference in the change in bone turnover marker between the two treatments. The two regimens were similarly tolerable. There were fewer adverse events in the monthly ibandronate group compared to the weekly risedronate group in terms of gastrointestinal side effects (nausea and abdominal distension). This study revealed a strong preference and convenience for monthly ibandronate over weekly risedronate in Korean postmenopausal osteoporotic women. There was no significant difference in change of bone turnover marker and safety profile between the two regimens.

Differential regulation of pregnancy associated plasma protein (PAPP)-A during pregnancy in human and mouse.

UNLABELLED: Serum IGFBP-4 proteolytic activity increases dramatically during human pregnancy and is mainly attributed to the pregnancy-associated plasma protein-A (PAPP-A). To understand the regulation and actions of PAPP-A in vivo, we evaluated the utility of a mouse model system. Serum from day-9 and day-17 pregnant mice and age-matched controls was tested for IGFBP-4 proteolytic activity using recombinant mouse IGFBP-4 as the substrate. Surprisingly, IGFBP-4 proteolytic activity in mouse pregnancy serum (mPS) was not significantly different from that of non-pregnancy serum (mNPS). Addition of IGF-II to mPS or mNPS at a dose sufficient to increase IGFBP-4 proteolysis by human PS failed to enhance IGFBP-4 proteolysis. PAPP-A neutralization antibody did not inhibit IGFBP-4 proteolysis by mPS or mNPS, but completely blocked IGFBP-4 proteolytic activity in human PS (hPS, mouse osteoblast conditioned medium, and mouse amniotic fluid). To determine whether the lack of PAPP-A activity in mPS was due to low expression of PAPP-A in the placenta, we cloned a mouse genomic DNA, which contained 1 kb of the entire exon 2 coding sequence and 2.5 kb of the flanking intron sequences. The exon 2-coded mouse and human PAPP-A shared 86% amino acid sequence identity. RT-PCR analysis revealed that the PAPP-A mRNA level in mouse placenta was lower compared to that in human placenta by at least two orders of magnitude. PAPP-A expression was also lower in mouse placenta compared to those in mouse kidney, osteoblasts, and bone marrow stromal cells. CONCLUSIONS: (1) Serum IGFBP-4 proteolytic activity is differentially regulated by pregnancy in human and mouse. (2) The lack of an increase in serum IGFBP-4 proteolytic activity during mouse pregnancy is due to the low level of PAPP-A expression in the placenta.