Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma

• Status: Recruiting
• Trial end date: 2023-05-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Diphosphonates; Zoledronic acid

Criteria

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.