1.Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes
Hyun Woong MUN ; Jong Joo LEE ; Hyun Chul SHIN ; Tae-Hwan KIM ; Seok Woo KIM ; Jae Keun OH
Neurospine 2025;22(1):69-77
Objective:
This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
Methods:
A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
Results:
At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Conclusion
Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
2.Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes
Hyun Woong MUN ; Jong Joo LEE ; Hyun Chul SHIN ; Tae-Hwan KIM ; Seok Woo KIM ; Jae Keun OH
Neurospine 2025;22(1):69-77
Objective:
This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
Methods:
A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
Results:
At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Conclusion
Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
3.Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes
Hyun Woong MUN ; Jong Joo LEE ; Hyun Chul SHIN ; Tae-Hwan KIM ; Seok Woo KIM ; Jae Keun OH
Neurospine 2025;22(1):69-77
Objective:
This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
Methods:
A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
Results:
At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Conclusion
Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
4.Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes
Hyun Woong MUN ; Jong Joo LEE ; Hyun Chul SHIN ; Tae-Hwan KIM ; Seok Woo KIM ; Jae Keun OH
Neurospine 2025;22(1):69-77
Objective:
This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
Methods:
A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
Results:
At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Conclusion
Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
5.Comparative Analysis of Romosozumab Versus Vertebroplasty With Denosumab: Efficacy, Safety, and Secondary Bone Mineral Density Outcomes
Hyun Woong MUN ; Jong Joo LEE ; Hyun Chul SHIN ; Tae-Hwan KIM ; Seok Woo KIM ; Jae Keun OH
Neurospine 2025;22(1):69-77
Objective:
This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
Methods:
A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
Results:
At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Conclusion
Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
6.Intensified First Cycle of Rituximab Plus Eight Cycles of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone with Rituximab Chemotherapy for Advanced-Stage or Bulky Diffuse Large B-Cell Lymphoma: A Multicenter Phase II Consortium for Improving Survival of Lymphoma (CISL) Study
Yu Ri KIM ; Jin Seok KIM ; Won Seog KIM ; Hyeon Seok EOM ; Deok-Hwan YANG ; Sung Hwa BAE ; Hyo Jung KIM ; Jae Hoon LEE ; Suk-Joong OH ; Sung-Soo YOON ; Jae-Yong KWAK ; Chul Won CHOI ; Min Kyoung KIM ; Sung Young OH ; Hye Jin KANG ; Seung Hyun NAM ; Hyeok SHIM ; Joon Seong PARK ; Yeung-Chul MUN ; Cheolwon SUH ;
Cancer Research and Treatment 2023;55(4):1355-1362
Purpose:
This phase II, open-label, multicenter study aimed to investigate the efficacy and safety of a rituximab intensification for the 1st cycle with every 21-day of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP-21) among patients with previously untreated advanced-stage or bulky diffuse large B-cell lymphoma (DLBCL).
Materials and Methods:
Ninety-two patients with stage III/IV or bulky DLBCL from 21 institutions were administered 8 cycles of R-CHOP-21 with an additional one dose of rituximab intensification on day 0 of the 1st cycle (RR-CHOP). The primary endpoint was a complete response (CR) rate after 3 cycles of chemotherapy.
Results:
Among the 92 DLBCL patients assessed herein, the response rate after 3 cycles of chemotherapy was 88.0% (38.0% CR+50.0% partial response [PR]). After the completion of 8 cycles of chemotherapy, the overall response rate was observed for 68.4% (58.7% CR+9.8% PR). The 3-year progression-free survival rate was 64.0%, and the 3-year overall survival rate was 70.4%. Febrile neutropenia was one of the most frequent grade 3 adverse events (40.0%) and 5 treatment-related deaths occurred. Compared with the clinical outcomes of patients who received R-CHOP chemotherapy as a historical control, the interim CR rate was higher in male patients with RR-CHOP (20.5% vs. 48.8%, p=0.016).
Conclusion
Rituximab intensification on days 0 to the 1st cycle of the standard 8 cycles R-CHOP-21 for advanced DLBCL yielded favorable response rates after the 3 cycles of chemotherapy and acceptable toxicities, especially for male patients. ClinicalTrials.gov ID: NCT01054781.
7.Treatment Efficacy of Various Maneuvers for Lateral Canal Benign Paroxysmal Positional Vertigo With Apogeotropic Nystagmus: A Randomized Controlled Trial
Hyun Jin LEE ; Eun-Ju JEON ; Sungil NAM ; Seog-Kyun MUN ; Shin-Young YOO ; Seong Hyun BU ; Jin Woong CHOI ; Jae Ho CHUNG ; Seok Min HONG ; Seung-Hwan LEE ; Min-Beom KIM ; Ja-Won KOO ; Hyun Ji KIM ; Jae-Hyun SEO ; Seong-Ki AHN ; Shi Nae PARK ; Minbum KIM ; Won-Ho CHUNG
Clinical and Experimental Otorhinolaryngology 2023;16(3):251-258
Objectives:
The aim of this study was to determine the most effective treatment approach by comparing the impacts of various otolith reduction techniques in patients with apogeotropic lateral semicircular canal benign paroxysmal positional vertigo (LC-BPPV).
Methods:
We performed a multicenter randomized prospective study from January to December 2015, involving 72 consecutive patients with apogeotropic LC-BPPV. The patients were divided into three treatment groups: therapeutic head-shaking (group A), the Gufoni-Appiani maneuver (group B), and the cupulolith repositioning maneuver (CuRM; group C). Each group underwent evaluation and treatment up to the fourth week. Treatment success was defined as the disappearance of positional vertigo and nystagmus.
Results:
This study included 72 patients (49 male and 23 female), with a mean (±standard deviation) age of 55.4±13.5 years. The mean duration of vertigo experienced prior to treatment was 3.9±4.4 days. The mean latency and duration of nystagmus were 2.7±3.0 seconds and 47.9±15.8 seconds, respectively. The overall treatment frequency was 2.0±0.9. The number of treatments differed significantly among the three groups (P<0.05). After 4 weeks, the success rates for groups A, B, and C were 90.5%, 92.3%, and 100%, respectively. No significant difference was observed in the success rate across treatment methods and periods (P>0.05). However, CuRM was the only method with a 100% treatment success rate.
Conclusion
While no clear difference was observed among the three treatments for LC-BPPV, CuRM was found to be superior to the other approaches in the long term.
8.Long-Term Efficacy and Safety of Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria and High Disease Burden: Real-World Data From Korea
Jin Seok KIM ; Jun Ho JANG ; Deog-Yeon JO ; Seo-Yeon AHN ; Sung-Soo YOON ; Je-Hwan LEE ; Sung-Hyun KIM ; Chul Won CHOI ; Ho-Jin SHIN ; Min-Kyoung KIM ; Jae Hoon LEE ; Yeung-Chul MUN ; Jee Hyun KONG ; BokJin HYUN ; HyunSun NAM ; Eunhye KIM ; Min Joo KWAK ; Yong Kyun WON ; Jong Wook LEE
Journal of Korean Medical Science 2023;38(41):e328-
Background:
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare hematologic disorder characterized by uncontrolled terminal complement activation. Eculizumab, a monoclonal antibody C5 inhibitor was introduced in Korea in 2009 and has been the standard treatment option for PNH.
Methods:
This study assessed the long-term efficacy/safety of eculizumab in PNH using real-world data from the Korean Health Insurance Review and Assessment Service. Eighty patients who initiated eculizumab from 2009–2020 were enrolled.
Results:
At eculizumab initiation, the median age was 51.5 years, lactate dehydrogenase (LDH) 6.8 × upper limit of normal, and granulocyte clone size 93.0%. All patients had at least one PNH-related complication before eculizumab initiation, including renal failure (n = 36), smooth muscle spasm (n = 24), thromboembolism (n = 20), and pulmonary hypertension (n = 15). The median (range) duration of eculizumab treatment was 52.7 (1.0, 127.3) months (338.6 total treated patient-years). Despite high disease activity in the study population before treatment initiation, overall survival was 96.2% and LDH levels were stabilized in most patients during treatment. PNH-related complications at treatment initiation were resolved in 44.4% of patients with renal failure, 95.8% with smooth muscle spasm, 70.0% with thromboembolism, and 26.7% with pulmonary hypertension. Extravascular hemolysis occurred in 28.8% of patients (n = 23; 0.09 per patient-year) and breakthrough hemolysis in 18.8% (n = 15; 0.06 per patient-year). No treatment discontinuation cases related to eculizumab were observed.
Conclusion
These data provided evidence for the long-term efficacy and safety of eculizumab in Korean PNH patients with high disease burdens.
9.Field evaluation of the safety and immunogenicity of a classical swine fever virus E2 subunit vaccine in breeding and nursery animals on Jeju Island, South Korea
Guehwan JANG ; Eun-Joo KIM ; Seong-Cheol CHO ; Sung-Up MOON ; Byeong Soo KIM ; Jinhee KIM ; Kyoung Ju JEONG ; Kyungok SONG ; Seong Hwan MUN ; Won-Myoung KANG ; Jonghoo LEE ; Changnam PARK ; Hyoung-Seok YANG ; Changhee LEE
Clinical and Experimental Vaccine Research 2022;11(3):264-273
Purpose:
Classical swine fever (CSF) reemerged on CSF-free Jeju Island where vaccination is not practiced by the unintentional injection of a live attenuated vaccine (modified live attenuated vaccines–low-virulence Miyagi [MLV-LOM]) in 2014. Since the Jeju provincial authority is considering adopting a voluntary immunization policy using a CSF-E2 subunit vaccine to combat LOM-derived CSF endemic, this study aimed to evaluate in Jeju herds.
Materials and Methods:
Two vaccination trials using the Bayovac CSF-E2 vaccine licensed for use in South Korea assessed the safety and humoral immunity of the CSF-E2 vaccine in breeding (trial 1) and nursery animals (trial 2) under farm application conditions.
Results:
Neither local nor systemic (including reproductive) adverse effects were objectively observed in pregnant sows and young piglets following a respective vaccination regime at pregnancy or weaning, respectively. Trial 1 showed that sows immunized with the CSF-E2 vaccine possessed high and consistent E2-specific and neutralizing antibody levels. The CSF-E2 vaccine-immunized pregnant sows subsequently conferred appropriate and steady passive immunity to their offspring. In trial 2, a double immunization scheme of the CSF-E2 vaccine in piglets at 40 and 60 days of age could elicit a consistent and long-lasting adequate antibody response. Additionally, the two trials detected no E rns -specific antibody responses, indicating that CSF-E2 vaccine can differentiate infected from vaccinated animals (DIVA).
Conclusion
Our trial data collectively provide invaluable information on applying the CSFE2 subunit vaccine to circumvent the possible drawbacks associated with the MLV-LOM concerning the safety, efficacy, and DIVA, in the LOM-endemic field farms and contribute to advanced CSF eradication on Jeju Island.
10.A Study on Verification of Equivalence and Effectiveness of Non-Pharmacologic Dementia Prevention and Early Detection Contents : Non-Randomly Equivalent Design
Hyun-Seok JEONG ; Oh-Lyong KIM ; Bon-Hoon KOO ; Ki-Hyun KIM ; Gi-Hwan KIM ; Dai-Seg BAI ; Ji-Yean KIM ; Mun-Seon CHANG ; Hye-Geum KIM
Journal of Korean Neurosurgical Society 2022;65(2):315-324
Objective:
: The aim of this study was to verify the equivalence and effectiveness of the tablet-administered Korean Repeatable Battery for the Assessment of Neuropsychological Status (K-RBANS) for the prevention and early detection of dementia.
Methods:
: Data from 88 psychiatry and neurology patient samples were examined to evaluate the equivalence between tablet and paper administrations of the K-RBANS using a non-randomly equivalent group design. We calculated the prediction scores of the tablet-administered K-RBANS based on demographics and covariate-test scores for focal tests using norm samples and tested format effects. In addition, we compared the receiver operating characteristic curves to confirm the effectiveness of the K-RBANS for preventing and detecting dementia.
Results:
: In the analysis of raw scores, line orientation showed a significant difference (t=-2.94, p<0.001), and subtests showed small to large effect sizes (0.04–0.86) between paper- and tablet-administered K-RBANS. To investigate the format effect, we compared the predicted scaled scores of the tablet sample to the scaled scores of the norm sample. Consequently, a small effect size (d≤0.20) was observed in most of the subtests, except word list and story recall, which showed a medium effect size (d=0.21), while picture naming and subtests of delayed memory showed significant differences in the one-sample t-test. In addition, the area under the curve of the total scale index (TSI) (0.827; 95% confidence interval, 0.738–0.916) was higher than that of the five indices, ranging from 0.688 to 0.820. The sensitivity and specificity of TSI were 80% and 76%, respectively.
Conclusion
: The overall results of this study suggest that the tablet-administered K-RBANS showed significant equivalence to the norm sample, although some subtests showed format effects, and it may be used as a valid tool for the brief screening of patients with neuropsychological disorders in Korea.

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