Safety and effectiveness of once-yearly zoledronic acid in Japanese osteoporosis patients: three-year post-marketing surveillance.

INTRODUCTION: Zoledronic acid (5 mg; ZOL), a once-yearly bisphosphonate, reduces osteoporotic fractures and increases bone mineral density (BMD). This 3-year post-marketing surveillance examined its real-world safety and effectiveness. MATERIALS AND METHODS: This prospective, observational study included patients who started ZOL for osteoporosis. Data were assessed at baseline, 12, 24, and 36 months for safety and effectiveness. Treatment persistence, potentially related factors, and persistence before and after the COVID-19 pandemic started were also investigated. RESULTS: The safety analysis and effectiveness analysis sets included 1406 and 1387 patients, respectively, with mean age of 76.5 years. Adverse reactions (ARs) occurred in 19.35% of patients, with an acute-phase reaction in 10.31, 1.01, and 0.55% after the first, second, and third ZOL infusions. Renal function-related ARs, hypocalcaemia, jaw osteonecrosis, and atypical femoral fracture occurred in 1.71, 0.43, 0.43, and 0.07% of patients, respectively. Three-year cumulative fracture incidences were 4.44% for vertebral, 5.64% for non-vertebral, and 9.56% for clinical fractures. BMD increased by 6.79, 3.14, and 1.78% at the lumbar spine, femoral neck, and total hip, respectively, after 3-year treatment. Bone turnover markers remained within reference ranges. Treatment persistence was 70.34% over 2 years and 51.71% over 3 years. Male, age ≥ 75 years, no previous medicines for osteoporosis, no concomitant medicines for osteoporosis, and inpatient at the first infusion were related to discontinuation. There was no significant difference in the persistence rate between before and after the COVID-19 pandemic (74.7% vs. 69.9%; p = 0.141). CONCLUSION: This 3-year post-marketing surveillance confirmed the real-world safety and effectiveness of ZOL.

Effects of immersion in virtual reality on postural control.

In the present study, we examined the effects of the time lag between visual scene and the head movement in the virtual reality (VR) world on motion sickness and postural control in healthy volunteers. After immersion in VR with additional time lags (from 0 to 0.8 s) to the inherent delay (about 250 ms), the visual-vestibular conflict induced a slight motion sickness in experimental subjects, but no change was noticed in the body sway path with eyes open and closed. However, Romberg ratio of body sway path with eyes closed divided by that with eyes open after immersion in VR was significantly decreased in comparison with that before immersion in VR. Since Romberg ratio is an index of visual dependency on postural control, this finding indicates that the immersion in VR decreases the visual dependency on postural control. It is suggested that adaptation to visual-vestibular conflict in VR immersion increases the contribution of vestibular and somatosensory inputs to postural control by ignoring the conflicting delayed visual input in the VR world. VR may be a promising treatment for visual vertigo in vestibular patients with unsuccessful compensation by its ability to induce vestibular and somatosensory reweighing for postural control.

Scaphoid fractures in children: problems and treatment.

From 1984 to 1999, the authors treated 64 cases of fracture of the scaphoid in children. Causes of injury were sports (n = 27), punching game machines or fighting (n = 22), and traffic accident or other trauma (n = 15). Most (46 cases) were nonunion cases. Eighteen cases were acute. Cast immobilization was performed in 10 acute cases and two nonunion cases. Screw fixation was performed in 52 cases, including 35 cases of bone graft. In 10 of these operated cases, freehand screw insertion was used. Ultimately, good bony fusion was achieved in all cases, but in two nonunion cases a secondary bone graft was necessary. Functional results in all cases were acceptable. A major problem is that children are not brought to clinics immediately after injury, so the percentage of nonunion is high.

Results of the latissimus dorsi and teres major tendon transfer on to the rotator cuff for brachial plexus palsy at birth.

Brachial plexus palsy at birth remains a serious problem. Although most cases resolve during the first few months by spontaneous regeneration, several operations have been used to correct the residual deformity. In the present study we describe the results of the latissimus dorsi and teres major tendons transfer on to the rotator cuff to improve shoulder function. Six patients were included in the study: three girls and three boys; four right shoulders, and two left. The types of palsy were four Erb's palsy (C5, C6) and two C5-C7 palsy. The median age at the time of operation was 11 years and 1 month and the median follow-up period was 54.2 months. Median preoperative passive external rotation was 51 degrees, and active abduction 67 degrees. Median postoperative active external rotation was 72 degrees, and postoperative active abduction 109 degrees. This procedure increased the ranges of external rotation and abduction, and provided considerable improvement in shoulder function.

Complications of vascularized fibula graft for reconstruction of long bones.

The clinical results and complications of the vascularized fibular graft for the reconstruction of various long bone defects were reviewed in 60 cases. Bony reconstruction was achieved in 57 of the 60 cases; however, various postoperative complications occurred in 54 percent of the cases. One case of arterial thrombosis of an anastomosed vessel and nine cases of venous congestion of the monitoring flap occurred in the early postoperative periods. The authors managed the nine cases of venous congestion of the flap conservatively, and all flaps survived. Partial necrosis of the flap was noted in eight of these nine cases, but additional surgical intervention was required in only four cases. Treatment included a gastrocnemius musculocutaneous flap in one case and a full-thickness skin graft in three cases. The vascularized fibula survived and bony fusion was achieved in all of these cases. The one case of arterial thrombosis resulted in graft failure due to a delay in the decision to perform a thrombectomy. Graft fracture occurred in 13 cases as the mechanical stress to the graft increased. In two cases of femoral reconstruction, graft fracture occurred during dynamization of the graft, despite the use of an Ilizarov external fixator. Correct alignment between the recipient bone and the external fixator is a prerequisite to preventing graft fracture. Vascularized fibular grafting offers the patient a great deal of benefit; however, this graft has a concomitant high risk of complications. Great attention to detail must be paid to prevent postoperative complications.