Clinical trial · Interventional
Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma
Non-inferiority Trial of Three Cycles of Zoledronic Acid Versus Percutaneous Thermal Ablation in Osteoid Osteoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoid Osteoma | Osteoid Osteoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acide Zoledronique | Drug | Zoledronic Acid | ALIAS |
| Thermal destruction with radiofrequency or laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1: Percutaneous treatment
- description
- Percutaneous treatment of OO is a thermal tumor destruction by radiofrequency or laser photocoagulation performed under CT control with strict aseptic approach and most often under general anesthesia. The introductive needle is inserted toward the nidus. Then the optic fiber or the radiofrequency probe is inserted in the nidus center and thermal destruction of the tumor is obtained.When the distance between the nidus and a nerve or the skin is less than 10 mm, infusion of normal saline or CO2 is introduced as spacing agent. When the nidus is in the subchondral bone, cold normal saline is introduced in the joint to protect the cartilage. In addition, a thermocouple is placed in the epidural or foraminal space to continuously monitor the temperature. A procedure typically required between 1 and 2 h from the time the patient entered the CT unit.
- interventionNames
- Device: Thermal destruction with radiofrequency or laser
- type
- EXPERIMENTAL
- label
- 2: Bisphosphonate treatment
- description
- The treatment consists of 3 infusions of zoledronic acid administered at a monthly interval. Bisphosphonate treatment is considered finished 1 month after the third bisphosphonate infusion (V4 visit). In few cases, the analgesic efficacy provided by 3 bisphosphonate infusions cannot be sufficient: 1 to 3 additional infusions could be proposed to the patient. Zoledronic acid is supplied as a 4 mg/100 ml solution for infusion. It will be administered as infusion over 30 minutes under the supervision of a nurse. Adults will receive intravenous infusion of 4 mg of zoledronic acid. Children will receive infusion of 0.025 mg/kg of zoledronic acid. The investigators propose abacus corresponding to zoledronic acid volume to infuse during 30 minutes for children.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
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 * Pregnant or breastfeeding women, or planning pregnancy during the course of the study * Women of child bearing potential (women following menarche and until post-menopause) and sexually active, without an effective contraceptive measure during the period of treatment (hormonal contraception or mechanical contraception)\* \* Oral contraceptive methods include: * combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravagina or transdermal) * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravagina or transdermal). * Mechanical methods of contraception include intrauterine device and intrauterine hormone-releasing system.Patient enrolled in another biomedical research protocol and during the whole study Patients who would not meet the inclusion criteria "OO percutaneously accessible" will be offered to participate in a register, only in Lariboisière hospital. This register will target specifically children aged of at least 12 years old and adults.
References
Publications (0)
Data not yet available