Purpose: Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice. Materials and Methods: This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed. Results: In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD. Conclusion Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.

Purpose: Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice. Materials and Methods: This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed. Results: In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD. Conclusion Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.

Purpose: Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice. Materials and Methods: This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed. Results: In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD. Conclusion Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.

Purpose: Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice. Materials and Methods: This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed. Results: In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD. Conclusion Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.

Purpose: Romosozumab reportedly increases bone density in patients with severe osteoporosis; however, data on its clinical effects are limited. We conducted a multicenter retrospective survey to study the bone density-increasing effects of romosozumab and blood test-based predictive factors in patients with severe osteoporosis, examining its effects in clinical practice. Materials and Methods: This was a multicenter retrospective observational study. The subjects were patients with severe osteoporosis who were treated with romosozumab at the participating facilities. The increase in bone density was assessed by comparing bone density changes (as a percentage) in the lumbar spine, femoral neck, and total femur before and 12 months after administration using dual-energy X-ray absorptiometry. The association between changes in bone density at each site and pre-treatment bone metabolism markers (Tracp 5b, P1NP), serum calcium levels, nutritional status [Conut score: albumin, total cholesterol (TCho), and total lymphocyte count], and kidney function (eGFR) was assessed. Results: In both naïve patients and those switching from bone resorption inhibitors, the bone density increased significantly. In naïve patients, eGFR were positively associated with bone density in the total femur. In cases of switching from bone resorption inhibitors, correlations were found between Tracp 5b and lumbar spine bone mineral density (BMD), as well as between Tracp 5b, Alb, T-Cho, and eGFR in the total femur BMD. Conclusion Romosozumab administration significantly increases bone density in osteoporosis, and assessing key predictive factors is necessary to ensure clinical effectiveness.

Methods: This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events. Results: Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events. Conclusions Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines.

Background/Aims: The aim of this study was to evaluate the safety of sedation with propofol as an alternative to benzodiazepine drugs in outpatient endoscopy. Methods: In this prospective study, examinees who underwent outpatient endoscopy under propofol sedation and submitted a nextday questionnaire with providing informed consent were evaluated. Periprocedural acute responses, late adverse events within 24 hours, and examinee satisfaction were evaluated. Results: Among the 4,122 patients who received propofol in the 17,978 outpatient-based endoscopic examinations performed between November 2016 and March 2018, 2,305 eligible examinees (esophagogastroduodenoscopy for 1,340, endoscopic ultrasonography for 945, and total colonoscopy for 20) were enrolled, and their responses to a questionnaire were analyzed. The mean propofol dose was 69.6±24.4 mg (range, 20–200 mg). Diazepam, midazolam, and/or pentazocine in combination with propofol was administered to 146 examinees. Mild oxygen desaturation was observed in 59 examinees (2.6%); and mild bradycardia, in 2 (0.09%). Other severe reactions or late events did not occur. After eliminating 181 invalid responses, 97.7% (2,065/2,124) of the patients desired propofol sedation in future examinations. Conclusions Propofol sedation was found to be safe—without severe adverse events or accidents—for outpatient endoscopy on the basis of the patients’ next-day self-evaluation. Given the high satisfaction level, propofol sedation might be an ideal tool for painless endoscopic screening.

Background/Aims: Probe-based confocal laser endomicroscopy (pCLE) requires the administration of intravenous (IV) fluorescein. This study aimed to determine the optimal dose of IV fluorescein for both upper and lower gastrointestinal (GI) tract pCLE. Methods: Patients 20 to 79 years old with gastric high-grade dysplasia (HGD) or colorectal neoplasms (CRNs) were enrolled in the study. The dose de-escalation method was employed with five levels. The primary endpoint of the study was the determination of the optimal dose of IV fluorescein for pCLE of the GI tract. The reduced dose was determined based on off-line reviews by three endoscopists. An insufficient dose of fluorescein was defined as the dose of fluorescein with which the pCLE images were not deemed to be visible. If all three endoscopists determined that the tissue structure was visible, the doses were de-escalated. Results: A total of 12 patients with gastric HGD and 12 patients with CRNs were enrolled in the study. Doses were de-escalated to 0.5 mg/kg of fluorescein for both non-neoplastic duodenal and colorectal mucosa. All gastric HGD or CRNs were visible with pCLE with IV fluorescein at 0.5 mg/kg. Conclusions In the present study, pCLE with IV fluorescein 0.5 mg/kg was adequate to visualize the magnified structure of both the upper and lower GI tract.

Purpose: In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. Materials and Methods: Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. Results: A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. Conclusion Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.

Purpose: In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. Materials and Methods: Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. Results: A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. Conclusion Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.