drugset / Trial / NCT02739555

Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma

NCT02739555

Phase 3 Terminated 15 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-06-23
Primary completion
2018-04-20
Completion
2019-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified 0.025 mg/kg Intravenous
Subject Zoledronic acid Other / unclassified 4 mg Intravenous

Indications