• Korean Journal of Clinical Pharmacy
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• v.33 no.2
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• pp.128-134
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• 2023

Background: This systematic review and meta-analysis aimed to evaluate the efficacy and cardiovascular safety of romosozumab compared with placebo. Methods: Randomized controlled trials (RCTs) were searched from Medline, EMBASE, Cochrane Central, and Web of Science until July 2022. Primary outcomes included the change in bone mineral density (BMD) from baseline at month 6. The secondary outcomes were the change of bone turnover markers (N-terminal propeptide of type 1 procollagen (P1NP); C-terminal telopeptide of type 1 collagen (CTX)) from baseline at month 3, and the incidence of cardiovascular adverse events for the total follow-up period. Results: A total of 7 RCTs on 8,370patients were included. Romosozumab showed better effects in improving BMD in both lumbar spine and femoral neck at month 6 (standardized mean difference, SMD 2.20 [95% CI: 1.89-2.52], SMD 0.63 [95% CI: 0.41-0.86]). In contrast to placebo, romosozumab significantly increased PINP levels and reduced CTX levels at month 3 (SMD 0.93 [95% CI: 0.65-1.22], SMD -1.03 [95% CI: -1.23~ -0.82]. However, there was no significant difference in the composite incidence of cardiovascular adverse events and major adverse cardiovascular events (OR 1.16 [95% CI: 0.82-1.65], OR 1.08 [95% CI: 0.75-1.56]). Conclusion: This analysis showed that romosozumab significantly improved BMD compared to placebo and was beneficial for change in bone turnover markers. There is no significant difference in the incidence of cardiovascular adverse events compared to placebo.

• CELLMED
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• v.13 no.14
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• pp.15.1-15.15
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• 2023

Background and objective: A new formular CPC22 consists of Cynanchum wilfordii root, Pueraria thomsonii flower, and Citrus unshiu peel and has been developed to improve the postmenopausal symptoms. The research intended to evaluate whether CPC22 would regulate bone loss, hot flashes, and dysregulated lipid metabolism in ovariectomized (OVX) postmenopausal mice. Method: The OVX mice were orally administered with CPC22 daily for 7 weeks. Results: CPC22 regulated OVX-induced bon loss by enhancing serum osteoprotegerin, alkaline phosphatase, and osteocalcin levels and diminishing serum receptor-activator of the NF-κB ligand (RANKL), collagen type 1 cross-linked N-telopeptide, and tartrate-resistant acid phosphatase levels. As a result of CPC22 treatment, notable decreases in tail skin temperature and rectal temperature were observed, along with diminishment in hypothalamic RANKL and monoamine oxidase A levels and enhancement in hypothalamic serotonin (5-HT), norepinephrine, dopamine, 5-HT2A, and estrogen receptor-β levels. CPC22 enhanced levels of serum estrogen and diminished levels of serum follicle-stimulating hormone and luteinizing hormone. CPC22 regulated levels of serum lipid metabolites, including total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Furthermore, CPC22 diminished levels of serum blood urea nitrogen, creatine kinase, alanine transaminase, aspartate aminotransferase, and lactate dehydrogenase and restored vaginal dryness without affecting uterus atrophy index and vagina weights. Conclusion: Therefore, these results indicated that CPC22 improves OVX-induced bone loss, hot flashes, and dysregulated lipid metabolism by compensating for estrogen deficiency without side effects, suggesting that CPC22 may be used for the prevention and treatment of post menopause.

• Journal of the Korean Society of Food Science and Nutrition
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• v.39 no.12
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• pp.1769-1775
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• 2010

Menopause is often associated with the incidence of several chronic diseases including osteoporosis, cardiovascular disease, and obesity. The purpose of this study was designed to evaluate the possibility of osteoporosis prevention in postmenopausal women. In this study, we investigated the effects of Ecklonia stolonifera (ES) extracts on bone turnover markers in ovariectomized rats. For this study, the following four groups of 9-week-old Sprague-Dawley rats were evaluated over 6 weeks: normal rats (SHAM), ovariectomized rats (OVX-CON) and ovariectomized rats that were treated with ES extracts. We measured the osteocalcin and C-telopeptide of collagen cross-links (CTx) content, enzyme ALP activity in serum and collagen content in the cartilage, bone, skin and lungs. We found that the levels of indicators of bone metabolism such as alkaline phosphatase (ALP), osteocalcin and CTx were lower in rats in the ES extract group than the OVX-CON group. In addition, the collagen contents in the bone, cartilage, skin and lungs decreased in response to ovariectomy, but the levels of collagen were greater in the bone of rats that were treated with ES extract than in the bone of rats in the OVX-CON group. These results suggest that the ES may be an effective functional food to prevent osteoporosis in postmenopausal women.

• Journal of Nutrition and Health
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• v.44 no.1
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• pp.29-40
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• 2011

The purpose of this study was to examine the association among bone mineral density (BMD), biochemical bone markers, nutrients, and salt intake in premenopausal and postmenopausal women. We evaluated 431 subjects who visited a health promotion center of a university hospital between January 2008 and July 2009. We excluded those who were taking medications or who had an endocrine disorder affecting osteoporosis. The subjects were divided into premenopausal (n = 283) and postmenopausal (n = 143) women. We evaluated the correlation among BMD of the lumbar spine, femoral neck, and total femoral, as well as biochemical bone markers, hormone, serum profiles, general characteristics, nutrient intakes, and food intake frequencies. From a stepwise multiple regression analysis, lumbar spine BMD was positively correlated with weight (p < 0.001) and negatively correlated with osteocalcin (OC)(p < 0.001), Femoral neck BMD was positively correlated with weight (p < 0.001) and negatively correlated with C-telopeptide (CTx) and alkaline phosphatase (ALP)(p < 0.001, p < 0.05). In premenopausal women, femoral total BMD was positively correlated with BMI (p < 0.001) and negatively correlated with CTx (p < 0.001). In postmenopausal women, lumbar spine BMD was positively correlated with calcium intake (p < 0.01) and negatively correlated with sodium intake (p < 0.01). Femoral neck and femoral total BMD were both positively correlated with weight (p < 0.001), and femoral neck BMD was negatively correlated with age and ALP (p < 0.001, p < 0.05). Femoral total BMD was negatively correlated with age and OC (p < 0.001, p < 0.01). These results suggest that reducing sodium intake may play an important role delaying bone resorption and preventing a decrease in BMD.

• Journal of the Korean Orthopaedic Association
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• v.54 no.6
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• pp.528-536
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• 2019

Purpose: This study examined the effects of a weekly teriparatide on the change in vertebral compression ratio, back pain, and vertebral fracture healing in osteoporosis patients with vertebral compression fractured induced by low energy trauma. Materials and Methods: From January 2016 to December 2017, 57 patients with severe osteoporotic vertebral fractures with a T score of -3.5 or less were included in this study. The changes in the vertebral compression ratio, visual analogue scale (VAS), Oswestry disability index (ODI) for at least 6 months were examined. The morphology of bone marrow edema and the presence of intervertebral cleft, osteocalcin, and N-terminal telopeptide (NTx) were also investigated. Results: The mean compression ratio was 20% in the experimental group (teripratide group) at 3 months, and 38% in the control group. A significant difference in the compression ratio of the vertebral body over time was observed (p<0.05; t-test). A comparison of the compression ratio of the vertebral body with the follow-up duration in each group showed no significant increase in the, compression (p=0.063) in the experimental group and a significant increase in the control group (p<0.05). The mean time to reach the plateau of the compression rate was one month in the experimental group and three months in the control group. The VAS score in the experimental and control group was 0.39 and 1.07 points, respectively. The ODI score in the experimental and control group was 33.72 and 39.52, respectively. At the last follow-up radiographs, there were no cases with an intervertebral cleft (0%) in the experimental group and 1 case (2.2%) in the control group. A significant difference in the osteocalcin level was observed between the injury and 6 months after the injury (p=0.003). In addition, there was no significant difference in the NTx level between the injury and 6 months after injury (p=0.960). Conclusion: In vertebral compression fractures patients with severe osteoporosis, a weekly teriparatide can promote the union of fractures, prevent further collapse of the vertebral body, and reduce the back pain faster.

• Journal of Trauma and Injury
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• v.18 no.2
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• pp.87-93
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• 2005

Background: The most frequent fracture seen at the emergency department (ED) in the elderly is a femur fracture whereas they do not know the degree of osteoporosis. We analyzed the degree of osteoporosis in patients with femur fractures and compared patients with only femur fractures (FX) to patients with femur and vertebral fractures (VX) by examining the clinical features, the bone mineral density (BMD), and biochemical markers. Methods: From January 2004 to December 2004, we enrolled prospectively 30 femur fracture patients who visited the ED. The bone mineral densities of the lumbar spine and the femur were examined. Total calcium, phosphate, alkaline phosphatase, osteocalcin, and serum C-terminal telopeptide (s-CTx) were measured. The patients with femur fractures were divided into two subgroups according to the presence of vertebral fracture. Results: All BMDs of the FX group showed osteoporosis. The s-CTx levels were higher than normal. The patients in the FX with VX were older than those in the FX only group, and had lower BMDs. There were no significant differences in markers between the subgroups, but the incidence of trochanteric fractures was higher in FX with VX group than in the FX only group. Conclusion: Femur fractures in the elderly were associated with osteoporosis. In our study, despite a considerable difference in BMD between patients with femur fractures and those with femur fractures combined with vertebral fractures, there was no difference in biochemical markers on bone formation nor in the those of bone resorption. We will further investigate the biochemical markers and BMD in the population of osteoporotic fractures. So those indicators should be helpful for planning treatment and for prevention of FX in the elderly.

• Journal of Korean Neurosurgical Society
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• v.58 no.4
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• pp.346-349
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• 2015

Objective : To investigate the value of lumbar bone mineral density (BMD) in fracture risk assessment (FRAX) tool. Methods : One hundred and ten patients aged over 60 years were enrolled and divided into 2 groups as non-osteoporotic vertebral fracture (OVF) and OVF groups. The 10-year-risk of major osteoporotic vertebral fracture of each group was calculated by FRAX tool with femoral and lumbar spine BMDs to compare the usefulness of lumbar spine BMD in prediction of OVF. The blood level of osteocalcin and C-terminal telopeptide (CTX) as markers of activities of osteoblast and osteoclast, respectively were analyzed using the institutional database. Results : In the OVF group, the ratio of patients with previous fracture history or use of glucocorticoid was higher than those in non-OVF group (p=0.000 and 0.030, respectively). The levels of T-score of femur neck and lumbar spine in OVF group were significantly lower than those in non-OVF group (p=0.001 and 0.000, respectively). The risk of OVF in FRAX using femur BMD in non-OVF and OVF groups was $6.7{\pm}6.13$ and $11.4{\pm}10.06$, respectively (p=0.007). The risk of using lumbar BMD in the 2 groups was $6.9{\pm}8.91$ and $15.1{\pm}15.08$, respectively (p=0.002). The areas under the receiver operator characteristic curve in the FRAX risk with lumbar and femur neck BMD were 0.726 and 0.684, respectively. The comparison of osteocalcin and CTX was not significant (p=0.162 and 0.369, respectively). Conclusion : In our study, the 10-year risk of major osteoporotic fracture in the OVF group of our study was lower than the recommended threshold of intervention for osteoporosis. Hence, a lower threshold for the treatment of osteoporosis may be set for the Korean population to prevent OVF. In the prediction of symptomatic OVF, FRAX tool using lumbar spine BMD may be more useful than that using femur neck BMD.

• Journal of Korean Neurosurgical Society
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• v.52 no.4
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• pp.281-287
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• 2012

Objective : To evaluate the effect of calcium supplementation on spinal bone fusion in ovariectomized (OVX) rats. Methods : Sixteen female Sprague Dawley rats underwent bilateral ovariectomy at 12 weeks of age to induce osteoporosis and were randomly assigned to two groups : control group (n=8) and calcium-supplemented group (OVX-Ca, n=8). Autologous spinal bone fusion surgery was performed on both groups 8 weeks later. After fusion surgery, the OVX-Ca group was supplemented with calcium in drinking water for 8 weeks. Blood was obtained 4 and 8 weeks after fusion surgery. Eight weeks after fusion surgery, the rats were euthanized and the L4-5 spine removed. Bone fusion status and fusion volume were evaluated by manual palpation and three-dimensional computed tomography. Results : The mean fusion volume in the L4-5 spine was significantly greater in the OVX-Ca group ($71.80{\pm}8.06mm^3$) than in controls ($35.34{\pm}8.24mm^3$) (p<0.01). The level of osteocalcin, a bone formation marker, was higher in OVX-Ca rats than in controls 4 weeks ($610.08{\pm}10.41$ vs. $551.61{\pm}12.34$ ng/mL) and 8 weeks ($552.05{\pm}19.67$ vs. $502.98{\pm}22.76$ ng/mL) after fusion surgery (p<0.05). The level of C-terminal telopeptide fragment of type I collagen, a bone resorption marker, was significantly lower in OVX-Ca rats than in controls 4 weeks ($77.07{\pm}12.57$ vs. $101.75{\pm}7.20$ ng/mL) and 8 weeks ($69.58{\pm}2.45$ vs. $77.15{\pm}4.10$ ng/mL) after fusion surgery (p<0.05). A mechanical strength test showed that the L4-5 vertebrae in the OVX-Ca group withstood a 50% higher maximal load compared with the controls (p<0.01). Conclusion : Dietary calcium given to OVX rats after lumbar fusion surgery improved fusion volume and mechanical strength in an ovariectomized rat model.

• Journal of Korean Neurosurgical Society
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• v.63 no.5
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• pp.623-630
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• 2020

Objective : A primary degenerative sagittal imbalance has been considered because of unique lifestyles such as the prolonged crouched posture during agricultural work and performing activities of daily living on the floor. Previous papers have reported that sagittal imbalance disease is often seen distinctly in the farming districts of "oriental" countries such as Korea and Japan. However, this finding was only evaluated with the use of X-ray, and other factors such as magnetic resonance imaging (MRI), muscle volume, compression fracture, and laboratory results were not considered. Thus, using these, we evaluate the agricultural work-associated factors for Korean elderly spinal sagittal imbalance. Methods : We recruited 103 Korean participants who had a sagittal vertical axis (SVA) of >5 cm in this Korean Elderly Sagittal Imbalance Cohort Study. The following were evaluated : radiological parameters, MRI, compression fracture, vitamin D, parathyroid hormone, C-terminal telopeptide, osteocalcin, bone mineral density and muscle fatty change, muscle volume, and health-related quality of life from patients' survey. Moreover, in this survey, the farmers' annual working hours were investigated. Subsequently, we analyzed the associated factors for spinal sagittal imbalance depending on occupation. Results : A total of 46 participants were farmers, and the others were housewives, sellers, and office workers. The farmer group had more SVA (141 vs. 99 mm, p=0.001) and pelvic tilt (31° vs. 24°, p=0.004) and lesser lumbar lordosis (20° vs. 30°, p=0.009) and thoracic kyphosis (24° vs. 33°, p=0.03) than non-farmer group. A significantly positive correlation was noted between the working hour and SVA in the farmer group (p=0.014). The visual analogue scale score for back pain (8.26 vs. 6.96, p=0.008) and Oswestry Disability Index (23.5 vs. 19.1, p=0.003) in the farmer group were higher than that in the non-farmer group, but the Short Form-36 score was not significantly different between the two groups. The Mini-Mental State Exam score was significantly lower in the farmer group than in the non-farmer group (24.85 vs. 26.98, p=0.002). Conclusion : The farmer group had more sagittal imbalance and back pain in proportion to the working hours even though the muscle and bone factors and general laboratory condition were not significantly different between the two groups. These results supported that the long hours spent in the crouched posture while performing agricultural work were a risk factor for severe sagittal imbalance.

• Journal of the Korean Society of Food Science and Nutrition
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• v.42 no.2
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• pp.195-202
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• 2013

This study was carried out to identify the relationship of biochemical bone turnover markers, bone mineral density (BMD), and general characteristics in Korean women. One hundred eighty healthy women, 20 to 50 years of age, living in Gwangju and Chonnam participated. Serum bone-specific alkaline phosphatase (BAP) and osteocalcin (OC) were used as bone formation markers and N-telopeptide of type 1 collagen (NTx) was used as a bone resorption maker to evaluate the state of bone turnover. T-scores were measured to evaluate BMD. We analyzed general characteristics, including age, menopause status, osteoporosis history, alcohol consumption, physical activity level, and degree of obesity (BMI, percent of fat). The BAP level significantly decreased in the group of twenty-year olds and increased in the non-alcohol consuming group, the group with a family history of osteoporosis, the menopause group, and the obese group (p<0.05). The OC level was lower in the group of twenty-year olds and increased in the non-alcohol intake group and the menopause group (p<0.05). BMD significantly decreased in the obese group (p<0.05). In conclusion, BAP and OC were affected by age, alcohol consumption, osteoporosis history, menopause status, and obesity. BMD was affected by obesity degree. These results suggest that the management of alcohol consumption and obesity are important for maintaining bone status during aging in Korean women.