1.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
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.
2.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
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.
3.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
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.
4.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
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.
5.Predictive Factors for Increased Bone Density Following Romosozumab Administration Based on Pre-Administration Blood Test Results
Akira KUWABARA ; Kazuhide INAGE ; Masaomi YAMASHITA ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masahiro INOUE ; Miyako SUZUKI-NARITA ; Takahisa HISHIYA ; Takahito ARAI ; Noriyasu TOSHI ; Kohei OKUYAMA ; Soichiro TOKESHI ; Susumu TASHIRO ; Shuhei OHYAMA ; Noritaka SUZUKI ; Seiji OHTORI
Yonsei Medical Journal 2025;66(4):226-232
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.
6.Association between Osteoporosis and Skeletal Muscle Mass in Men
Masaya MIZUTANI ; Yawara EGUCHI ; Toru TOYOGUCHI ; Sumihisa ORITA ; Kazuhide INAGE ; Yasuhiro SHIGA ; Satoshi MAKI ; Junichi NAKAMURA ; Shigeo HAGIWARA ; Yasuchika AOKI ; Masahiro INOUE ; Masao KODA ; Hiroshi TAKAHASHI ; Tsutomu AKAZAWA ; Seiji OHTORI
Asian Spine Journal 2024;18(1):73-78
Methods:
This study included 99 men (mean age, 74.9 years; range, 28–93 years) who visited Qiball Clinic for BMD and body composition examinations. The osteoporosis group consisted of 24 patients (mean age, 72.5 years; range, 44–92 years), and the control group consisted of 75 individuals (mean age, 74.9 years; range, 28–93 years). Whole-body skeletal muscle mass was measured using a bioelectrical impedance analyzer. BMD was measured by dual X-ray absorptiometry. Skin autofluorescence (SAF), a marker of dermal AGE accumulation, was measured using a spectroscope. Osteoporosis was defined as a bone density T score of –2.5 or less. Physical findings, skeletal muscle mass, BMD, grip strength, and SAF were compared between the osteoporosis and control groups.
Results:
The osteoporosis group had significantly lower trunk muscle mass (23.1 kg vs. 24.9 kg), lower leg muscle mass (14.4 kg vs. 13.0 kg), and skeletal mass index (7.1 kg/m2 vs. 6.7 kg/m2) than the control group (all p<0.05). Lower limb muscle mass was identified as a risk factor for osteoporosis in men (odds ratio, 0.64; p=0.03).
Conclusions
Conservative treatment of osteoporosis in men will require an effective approach that facilitates the maintenance or strengthening of skeletal muscle mass, including exercise therapy with a focus on lower extremities and nutritional supplementation.
7.Differences in Risk Factors for Decreased Cervical Lordosis after Multiple-Segment Laminoplasty for Cervical Spondylotic Myelopathy and Ossification of the Posterior Longitudinal Ligament: A Pilot Study
Takaki INOUE ; Satoshi MAKI ; Takeo FURUYA ; Sho OKIMATSU ; Atsushi YUNDE ; Masataka MIURA ; Yuki SHIRATANI ; Yuki NAGASHIMA ; Juntaro MARUYAMA ; Yasuhiro SHIGA ; Kazuhide INAGE ; Sumihisa ORITA ; Yawara EGUCHI ; Seiji OHTORI
Asian Spine Journal 2023;17(4):712-720
Methods:
This study included 50 patients with CSM and 39 with C-OPLL who underwent multi-segment laminoplasty. Decreased CL was defined as the difference between preoperative and 2-year postoperative neutral C2–7 Cobb angles. Radiographic parameters included preoperative neutral C2–7 Cobb angles, C2–7 sagittal vertical axis (SVA), T1 slope (T1S), dynamic extension reserve (DER), and range of motion. The radiographic risk factors were investigated for decreased CL in CSM and C-OPLL. Additionally, the Japanese Orthopedic Association (JOA) score was assessed preoperatively and 2 years postoperatively.
Results:
C2–7 SVA (p =0.018) and DER (p =0.002) were significantly correlated with decreased CL in CSM, while C2–7 Cobb angle (p =0.012) and C2–7 SVA (p =0.028) were correlated with decreased CL in C-OPLL. Multiple linear regression analysis revealed that greater C2–7 SVA (B =0.22, p =0.026) and small DER (B =−0.53, p =0.002) were significantly associated with decreased CL in CSM. By contrast, greater C2–7 SVA (B =0.36, p =0.031) was significantly associated with decreased CL in C-OPLL. The JOA score significantly improved in both CSM and C-OPLL (p <0.001).
Conclusions
C2–7 SVA was associated with a postoperative decreased CL in both CSM and C-OPLL, but DER was only associated with decreased CL in CSM. Risk factors for decreased CL slightly differed depending on the etiology of the condition.
8.Improvements in Intractable Lumbar and LowerExtremity Symptoms after Systemic Administration of Tocilizumab, an Anti-interleukin-6 Receptor Antibody
Takeshi SAINOH ; Takeshi SAINOH ; Sumihisa ORITA ; Sumihisa ORITA ; Masayuki MIYAGI ; Masayuki MIYAGI ; Miyako SUZUKI-NARITA ; Miyako SUZUKI-NARITA ; Yoshihiro SAKUMA ; Yoshihiro SAKUMA ; Yasuhiro OIKAWA ; Yasuhiro OIKAWA ; Go KUBOTA ; Go KUBOTA ; Jun SATO ; Jun SATO ; Yasuhiro SHIGA ; Yasuhiro SHIGA ; Kazuki FUJIMOTO ; Kazuki FUJIMOTO ; Yawara EGUCHI ; Yawara EGUCHI ; Masao KODA ; Masao KODA ; Yasuchika AOKI ; Yasuchika AOKI ; Tsutomu AKAZAWA ; Tsutomu AKAZAWA ; Takeo FURUYA ; Takeo FURUYA ; Junichi NAKAMURA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Hiroshi TAKAHASHI ; Satoshi MAKI ; Satoshi MAKI ; Masahiro INOUE ; Masahiro INOUE ; Hideyuki KINOSHITA ; Hideyuki KINOSHITA ; Masaki NORIMOTO ; Masaki NORIMOTO ; Takashi SATO ; Takashi SATO ; Masashi SATO ; Masashi SATO ; Masahiro SUZUKI ; Masahiro SUZUKI ; Keigo ENOMOTO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Norichika MIZUKI ; Takashi HOZUMI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Ryuto TSUCHIYA ; Geundong KIM ; Geundong KIM ; Takuma OTAGIRI ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Takahisa HISHIYA ; Seiji OHTORI ; Seiji OHTORI ; Kazuhide INAGE ; Kazuhide INAGE
Asian Spine Journal 2022;16(1):99-106
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.
9.Usefulness of Simultaneous Magnetic Resonance Neurography and Apparent T2 Mapping for the Diagnosis of Cervical Radiculopathy
Keigo ENOMOTO ; Yawara EGUCHI ; Takashi SATO ; Masaki NORIMOTO ; Masahiro INOUE ; Atsuya WATANABE ; Takayuki SAKAI ; Masami YONEYAMA ; Yasuchika AOKI ; Sumihisa ORITA ; Miyako NARITA ; Kazuhide INAGE ; Yasuhiro SHIGA ; Tomotaka UMIMURA ; Masashi SATO ; Masahiro SUZUKI ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Geundong KIM ; Takashi HOZUMI ; Naoya HIROSAWA ; Takeo FURUYA ; Satoshi MAKI ; Junichi NAKAMURA ; Shigeo HAGIWARA ; Masao KODA ; Tsutomu AKAZAWA ; Hiroshi TAKAHASHI ; Kazuhisa TAKAHASHI ; Seiji OHTORI
Asian Spine Journal 2022;16(1):47-55
Methods:
A total of 14 patients with unilateral radicular symptoms and five healthy subjects were subjected to simultaneous apparent T2 mapping and neurography with nerve-sheath signal increased with inked rest-tissue rapid acquisition of relaxation enhancement signaling (SHINKEI-Quant) using a 3-Tesla magnetic resonance imaging. The Visual Analog Scale (VAS) score for neck pain and upper arm pain was used to evaluate clinical symptoms. T2 relaxation times of the cervical dorsal root ganglia of the brachial plexus were measured bilaterally from C4 to C8 in patients with radicular symptoms and from C5 to C8 in healthy controls. The T2 ratio was calculated as the affected side to unaffected side.
Results:
When comparing nerve roots bilaterally at each spinal level, no significant differences in T2 relaxation times were found between patients and healthy subjects. However, T2 relaxation times of nerve roots in the patients with unilateral radicular symptoms were significantly prolonged on the involved side compared with the uninvolved side (p<0.05). The VAS score for upper arm pain was not significantly correlated with the T2 relaxation times, but was positively correlated with the T2 ratio.
Conclusions
In patients with cervical radiculopathy, the SHINKEI-Quant technique can be used to quantitatively evaluate the compressed cervical nerve roots. The VAS score for upper arm pain was positively correlated with the T2 ratio. This suggests that the SHINKEI-Quant is a potential tool for the diagnosis of cervical nerve entrapment.
10.Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study
Kazuhide INAGE ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masao KODA ; Yasuchika AOKI ; Toshiaki KOTANI ; Tsutomu AKAZAWA ; Takeo FURUYA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Miyako SUZUKI-NARITA ; Satoshi MAKI ; Shigeo HAGIWARA ; Masahiro INOUE ; Masaki NORIMOTO ; Hideyuki KINOSHITA ; Takashi SATO ; Masashi SATO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Geundong KIM ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Seiji OHTORI
Yonsei Medical Journal 2021;62(9):829-835
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.

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