#1 Clinical Trials Search in Europe

SODIUM IBANDRONATE

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.

Table of Contents

Trial overview

The source data include one completed interventional study that lists SODIUM IBANDRONATE among its related treatment options.[1] The trial is focused on osteogenesis imperfecta and is designed to study fracture outcomes in this patient group.[1]

Condition and population

The condition studied is osteogenesis imperfecta, which is a disorder linked to fragile bones and a higher risk of fractures.[1] 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.[1]

Study design and phase

This is an interventional study, which means the researchers tested a treatment plan and followed what happened to the participants.[1] 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.[1]

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.[1] Standard care could mean no active treatment or treatment with bisphosphonates, depending on patient preference and normal care provider practice.[1] The intervention list also includes SODIUM IBANDRONATE-related products among several bone treatments recorded in the trial data.[1]

Main outcome measured

The main outcome is the proportion of participants who have a clinical fracture confirmed by x-ray or other imaging.[1] This is the primary outcome, meaning it is the most important result the researchers planned to measure.[1] 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.[1]

Study status and size

The trial is marked as completed in the source data.[1] The enrollment number is 360, which means 360 participants were planned or included in the study record.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519705-36-00 Phase 3 Osteogenesis imperfecta Completed 360

FAQ

  • What is being studied in trials involving SODIUM IBANDRONATE? The trial data show a study in osteogenesis imperfecta that compares a treatment plan with standard care. The main goal is to see whether the study treatment lowers the number of fractures confirmed by x-ray or other imaging.
  • Who may take part in these trials? The trial is for people with osteogenesis imperfecta. The provided data do not list detailed age limits or other exact entry rules.
  • What phase is the study? The trial is a Phase 3 study. Phase 3 studies usually test how well a treatment works in a larger group of people and compare it with usual care.
  • What outcome is the trial measuring? The main outcome is the proportion of participants who have a clinical fracture confirmed by x-ray or other imaging. The study is event driven, which means it ends after a set number of fracture events happen.
  • Is the study completed? Yes. The trial listed in the source data is marked as completed. It enrolled 360 participants.

Ongoing Clinical Trials on SODIUM IBANDRONATE

  • Study on Treating Osteogenesis Imperfecta in Patients Using Teriparatide and Zoledronic Acid

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Ireland The Netherlands

Glossary

  • Osteogenesis imperfecta: A condition that makes bones fragile and more likely to break.
  • Interventional study: A type of clinical trial where researchers give a treatment and watch what happens.
  • Phase 3: A later stage of testing that studies how well a treatment works in a larger group of people.
  • Enrollment: The number of people who joined the study.
  • Primary outcome: The main result the researchers want to measure.
  • Clinical fracture: A broken bone that is counted in the study because it is confirmed as a real fracture.
  • X-ray: An imaging test that uses radiation to help show bones and injuries inside the body.
  • Other imaging: Other scan tests used to confirm a fracture when needed.
  • Event driven study: A study that ends after a set number of important events, such as fractures, have happened.
  • Standard care: The usual treatment or follow-up that people would normally receive.

References

  1. https://clinicaltrials.gov/study/2024-519705-36-00