In short
Clinical trials investigating SODIUM IBANDRONATE are studying treatment approaches for people with osteogenesis imperfecta, a condition linked to fragile bones. The trials look at whether treatment strategies can reduce fractures and how they compare with standard care. They include patients in an interventional Phase 3 study.
Key points
- Clinical trial data for SODIUM IBANDRONATE focus on osteogenesis imperfecta, a condition that causes fragile bones. The main study is an interventional Phase 3 trial with 360 participants. It measures how many people have a clinical fracture confirmed by x-ray or other imaging. The trial is completed and uses an event-driven design, ending after a planned number of fracture events. The source data also show that the study compares a treatment strategy with standard care.
Trial overview
The source data include one completed interventional study that lists SODIUM IBANDRONATE among its related treatment options. The trial is focused on osteogenesis imperfecta and is designed to study fracture outcomes in this patient group.
Condition and population
The condition studied is osteogenesis imperfecta, which is a disorder linked to fragile bones and a higher risk of fractures. The trial data do not give detailed age limits or other full entry rules, so the exact participant profile cannot be expanded beyond the condition stated in the source.
Study design and phase
This is an interventional study, which means the researchers tested a treatment plan and followed what happened to the participants. It is a Phase 3 trial, so it is in a later testing stage and is meant to assess how well the study approach works in a larger group.
Treatments compared
The brief summary says the study tested a two-year treatment spell with teriparatide, followed by zoledronic acid, and compared this plan with standard care. Standard care could mean no active treatment or treatment with bisphosphonates, depending on patient preference and normal care provider practice. The intervention list also includes SODIUM IBANDRONATE-related products among several bone treatments recorded in the trial data.
Main outcome measured
The main outcome is the proportion of participants who have a clinical fracture confirmed by x-ray or other imaging. This is the primary outcome, meaning it is the most important result the researchers planned to measure. The study is event driven, which means it ends after 139 participants have had a confirmed fracture event, and this was expected after an average of 62 months of follow-up.
Study status and size
The trial is marked as completed in the source data. The enrollment number is 360, which means 360 participants were planned or included in the study record.