Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma (NCT02739555) | Clinical Trial Compass
TerminatedPhase 3
Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma
Stopped: The study has been conducted until the end of the research; participants are no longer receiving an intervention or being examined; but recruitment isn't completed (15 % enrolled in the stud)
France15 participantsStarted 2016-06-23
Plain-language summary
Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults, responsible for intense bone pain, which has a tendency to spontaneously heal with mineralization of the nidus, but extremely slowly. This healing may be accelerated in patients taking NSAIDs regularly during a few years. The long delay for healing and intense pain, explain why patients are quickly directed to surgeons or specialized radiology departments for tumor ablation. But percutaneous treatment or surgical excision destruction can expose the patient to a substantial risk in terms of neurologic or joint damages, depending on the location. Bisphosphonates treatment may be an effective alternative to percutaneous treatment by accelerating the natural history of OO.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age superior or equal to 10 years
* Patient with a typical osteoid osteoma diagnosed on clinical and radiological criteria (MRI and scanner), validated by a binomial clinician / radiologist.
* OO never treated or in treatment failure, or recurrent OO.
* OO percutaneously accessible
* Pain intensity is superior or equal to 40 mm on a VAS at inclusion visit.
* Written informed consent signed by the patient or his representative (for minors, agreement of the child and signature of the two mandatory parents).
* Patient affiliated to the social security.
Exclusion Criteria:
* Patients with other diseases or receiving treatment that may impact on bone tissue or its metabolism.
* Patients suffering from renal failure (i.e. lower than 60 ml/min according to the Cowcroft equation).
* Patients with severe hepatocellular insufficiency (TP\<50%).
* Patients with a history of iritis or uveitis.
* Patient with untreated rickets or osteomalacia.
* Patient with untreated dental infection or planed dental surgery during the study period.
* Patient with untreated infection of the external auditory canal (ex: furuncle, eczema superinfection)
* Patient already treated by bisphosphonates.
* Patients with hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients (List of excipients: mannitol (E421), sodium citrate (E331), water for injections).
* Patient enrolled in another biomedical research protocol and during the whole study
* Pregn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of decrease in bone pain measured on a visual analog scale (VAS) between baseline and the end of treatment larger or equal to 70%.