Table of contents

• Trial overview
• Condition and target population
• Study design and phase
• Main outcome measured
• Treatments listed in the trial record
• What this means for patients

Trial overview

The trial record for SODIUM IBANDRONATE is part of a larger study focused on bone disease research. The main study listed is a Phase 3, interventional trial with status Completed and planned enrollment of 360 participants.^[1]

The study title is “Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid,” and the brief summary explains that it tests whether a two-year course of teriparatide followed by zoledronic acid can lower the chance of fracture compared with standard care.^[1]

Condition and target population

The condition being studied is osteogenesis imperfecta.^[1] This is the patient group the trial is designed for, so the research is aimed at people living with this bone disorder rather than a general population.

The trial data do not provide detailed inclusion or exclusion criteria, so the exact rules for who can join are not shown in the source material.^[1] From the information given, the key target population is people with osteogenesis imperfecta who are being considered for bone treatment strategies.

Study design and phase

This is an interventional study, which means researchers are testing a treatment plan and comparing it with another care approach.^[1] The phase is Phase 3, a late-stage trial that usually looks at whether a treatment works in a larger group of participants.^[1]

The study is described as event driven, meaning it is planned to continue until a certain number of fracture events has happened.^[1] In this case, the trial will end when 139 participants have had an incident clinical fracture confirmed by imaging.^[1]

Main outcome measured

The primary outcome is the proportion of participants experiencing a clinical fracture validated by X-ray or other imaging.^[1] In simple terms, the study wants to know how many people in each study group break a bone during follow-up.

This outcome is important because it focuses on a real patient problem: fractures that are confirmed by medical imaging, not just symptoms alone.^[1] The brief summary also says the expected average follow-up is about 62 months, which is a little over five years.^[1]

Treatments listed in the trial record

The intervention list in the trial record includes several bone-related medicines, such as SODIUM IBANDRONATE in different product forms, along with alendronic acid, risedronate sodium, zoledronic acid, teriparatide, denosumab, pamidronate, calcium and vitamin D products.^[1] These names appear in the source as part of the study record and related treatment context.

The brief summary states that the main comparison is between a treatment strategy using teriparatide followed by zoledronic acid and standard care, which may include no active treatment or bisphosphonate treatment depending on patient and provider preference.^[1] The source does not explain why SODIUM IBANDRONATE is listed among the interventions, so the article should not assume a role beyond what is written in the trial record.^[1]

What this means for patients

For patients, this trial is mainly about finding better ways to reduce fractures in osteogenesis imperfecta.^[1] The most important result is whether the treatment approach lowers the number of confirmed fractures over time.

Because the study is already completed, the record is useful for understanding what was tested and what outcomes were measured.^[1] The source material does not report the final results, so only the study design and goals can be described here.^[1]