Clinical Trial: Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Non-inferiority Trial of Three Cycles of Zoledronic Acid Versus Percutaneous Thermal Ablation in Osteoid Osteoma

Brief 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.

Detailed Summary:

Osteoid osteomas (OOs) are small, benign but painful bone tumors, mainly observed in children and young adults. Pain, almost universal, is characteristically greater at night. Pain is well relieved by NSAIDs but resolution is not always complete and pain reappears a few hours after the last dose. Also long-term consumption of NSAID can lead to serious adverse events. Therefore OOs are usually cured shortly after diagnosis, mainly by means of percutaneous treatment (PT) under computed tomography (CT) (radiofrequency coagulation or interstitial laser ablation).

The clinical success rate using these techniques is 96% at 6-month, 94% at 24-month. However, the technique is not distributed everywhere since it is performed by highly specialized interventional radiologists. The PT is performed under general, spinal or regional anesthesia. General anesthesia is used in most cases, especially in children. When the OO is located in close proximity to the skin, cartilage, vessels and nerves, severe complications may occur and additional procedures such as infusion of saline or injection of CO2 at the interface between the OO and the vulnerable structure are done. Also few anatomic locations are not accessible to a PT.

The natural history of OOs remains poorly understood. However investigators in small series of conservatively treated OOs suggested a spontaneous healing of the lesion with mineralization of the nidus and resolution of pain (mean duration of pain in patients with NSAID treatment: 33 months NSAID).

The efficacy of bisphosphonates on pain related to benign (Langherhans cell histiocytosis, fibrous dysplasia, Paget disease) or malignant bone lesions has been widely reported. The investigators observed such efficacy in a small series of 20 patients with percutaneously hard-to-
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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%. [ Time Frame: 4 months ]

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%. End of treatment is set at one month after the third administration of bisphosphonates and three months after the percutaneous thermal destruction (ie 4 months after inclusion visit = V4 visit, for both groups).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain [ Time Frame: at 1, 2, 3, 7, 10 and 16 months ]

    arm1 : only at 16 months

    arm 2 : assessed by Visual Analog Scale 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) [ Time Frame: at 2, 3, 7, 10 and 16 months ]

    arm1 : only at 16 months

    arm 2 : assessed by Visual Analog Scale as an average over the past 48 hours, at 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)

  • Consumption of analgesic and NSAIDs [ Time Frame: at inclusion, 1, 2, 3, 4, 7, 10 and 16 months ]
    To this end, patient will be asked to note any analgesic and NSAIDs medication in a CRJ during the whole study arm1 : only at inclusion, 1, 4 and16 months
  • Nidus mineralization on CT scan images [ Time Frame: 4 months ]
  • Surface of bone marrow edema on MR images [ Time Frame: at 4 and 16 months ]
  • Incidence of Treatment-Emergent Adverse Events of bisphosphonates and percutaneous treatment. [ Time Frame: at inclusion, 1, 2, 3, 4, 7, 10 and 16 months ]

    Tolerance and adverse events of bisphosphonates and percutaneous treatment. To this end, patient will be asked to note any adverse event in a CRJ during the whole study.

    arm1 : only at inclusion, 1, 4 and16 months



Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 29, 2016
Date Started: June 2016
Date Completion: October 2020
Last Updated: December 14, 2016
Last Verified: December 2016