MedDRA version: 18.1 Level: PT Classification code 10031249 Term: Osteoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Acide zolédronique
Product Name: Acide zolédronique
Product Code: EU/1/01/176/003
Pharmaceutical Form: Powder and solvent for solution for infusion
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age superior or equal to 10 years - Patient with a typical osteoid osteoma diagnosed on clinical and radiological criteria, validated by a binomial clinician / radiologist Both radiological exams should not be older than 3 months prior to inclusion visit (if not, to be repeated before treatment). - OO never treated 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. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 hepatic impairment, which may alter the rate of alkaline phosphatase, such as hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hepatic cirrhosis. - 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). - Pregnant or breastfeeding women, or women of child bearing potential (women following menarche and until post-menopause) planning pregnancy during the course of the study (a highly effective contraceptive measure is required during the period of treatment.) - Patient enrolled in another biomedical research protocol and during the whole study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that in patients with OO, treatment with three intravenous cycles of 4mg of zoledronic acid (Zoledronic acid) administered monthly, is non-inferior to treatment with percutaneous thermal ablation on the efficacy measured by the percentage of pain relief between baseline and end of treatment. ;Secondary Objective: To demonstrate that in patients with OO, treatment with three intravenous cycles of 4mg of zoledronic acid (Zoledronic acid) administered monthly, is non-inferior to treatment with percutaneous thermal ablation on the efficacy measured by the percentage of pain relief between baseline and end of treatment. ;Primary end point(s): Success of treatment: Success is defined as a percentage of decrease in bone pain measured on a visual analog scale (VAS) between baseline (inclusion visit) and the end of treatment larger or equal to 70%. End of treatment is set at one month after the last administration of bisphosphonates and three months after the percutaneous thermal destruction (ie 4 months after inclusion visit = V4 visit, for both groups).;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Success of treatment: Success is defined as a percentage of decrease in bone pain measured on a visual analog scale (VAS) between baseline (inclusion visit) and the end of treatment larger or equal to 70%. End of treatment is set at one month after the last administration of bisphosphonates and three months after the percutaneous thermal destruction (ie 4 months after inclusion visit = V4 visit, for both groups).;Timepoint(s) of evaluation of this end point: •Pain, assessed by Visual Analog Scale (VAS, annex 2) as an average over the past 48 hours, at V1 (1 month +/- 5 days), V2 (2 months +/- 5 days), V3 (3 months +/- 5 days), V7 visits (16 months +/- 1 month) and, in case of additional infusions, at V5 (7 months +/- 15 days) and V6 (10 months +/- 15 days) •Patient'Global Impression of change (PGIC) from V2 to V7 visits (PµGIC, annex 3). •Consumption of analgesic and NSAIDs: | — |
Countries
France
Outcome results
None listed