ABSTRACT
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).
ABSTRACT
BACKGROUND/AIMS: Percutaneous endoscopic gastrostomy (PEG) is a method of providing enteral nutrition using endoscopy. The PEG techniques differ according to the insertion method, and include the pull type, push type, and introducer type. The aim of this study was to compare the clinical outcomes associated with the pull-type and introducer-type PEG insertion techniques, which included the adverse events, at our tertiary care center in Korea. METHODS: We retrospectively reviewed 141 cases that had undergone PEG insertion at our center from January 2009 to June 2012. The indications for PEG insertion and the acute and chronic complications caused by each type of PEG insertion were analyzed. RESULTS: The indications for PEG insertion in our cohort included neurologic disease (58.7%), malignancy (21.7%), and other indications (19.6%). Successful PEG insertions were performed on 136 cases (96.5%), and there were no PEG-associated deaths. Bleeding was the most frequent acute complication (12.8%), and wound problems were the most frequent chronic complications (8.8%). There were no statistically significant differences between the pull-type and introducer-type PEG insertion techniques in relation to complication rates in our study population. CONCLUSIONS: PEG insertion is considered a safe procedure. The pull-type and introducer-type PEG insertion techniques produce comparable outcomes, and physicians may choose either of these approaches according to the circumstances.