Iwata

Researchers are evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in women with osteoporosis who have recently had a hip fracture repaired. This randomized controlled trial involves up to 2400 postmenopausal women aged 65 to 91 years who have experienced a low-energy fragility hip fracture and are undergoing surgical repair. The study aims to reduce the incidence of new fractures on the opposite hip, which is at risk during recovery. Participants are randomly assigned to one of two groups: the treated group receives standard hip fracture repair plus the AGN1 LOEP treatment on the unfractured opposite hip, while the control group receives only the standard repair without the AGN1 procedure. The AGN1 LOEP treatment involves injecting the implant material at the treatment site immediately after hip surgery. Follow-up visits are scheduled at 6 weeks, 6 months, and then every 6 months for at least 5 years to monitor outcomes. During the study, participants will undergo assessments to track the occurrence of secondary hip fractures and any adverse events, including serious complications. Researchers will collect data at multiple visits to evaluate the procedure's safety and effectiveness over time. The main outcomes measured include the cumulative incidence of new hip fractures and adverse events approximately 30 months after treatment, with long-term follow-up continuing for a minimum of five years.

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.