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Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma (BISPHOO)

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ClinicalTrials.gov Identifier: NCT02739555
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Osteoid Osteoma Device: Thermal destruction with radiofrequency or laser Drug: Acide Zoledronique Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-inferiority Trial of Three Cycles of Zoledronic Acid Versus Percutaneous Thermal Ablation in Osteoid Osteoma
Actual Study Start Date : June 23, 2016
Estimated Primary Completion Date : April 25, 2022
Estimated Study Completion Date : May 24, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1: Percutaneous treatment
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.
Device: Thermal destruction with radiofrequency or laser
Experimental: 2: Bisphosphonate treatment

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.

Drug: Acide Zoledronique



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)


  2. 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)


  3. 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

  4. Nidus mineralization on CT scan images [ Time Frame: 4 months ]
  5. Surface of bone marrow edema on MR images [ Time Frame: at 4 and 16 months ]
  6. 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




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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739555


Contacts
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Contact: Valérie BOUSSON, MD, PhD +331 4995 6180 valerie.bousson@aphp.fr

Locations
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France
Hopital PELLEGRIN - Service d'imagerie diagnostique et interventionnelle de l'adulte Recruiting
Bordeaux, France, 33000
Contact: Olivier HAUGER, PUPH       olivier.hauger@chu-bordeaux.fr   
Hopital PELLEGRIN - Service rhumatologie Recruiting
Bordeaux, France, 33000
Contact: Nadia MEHSEN-CETRE, PH       nadia.mehsen@chu-bordeaux.fr   
Hôpital ROGER SALENGRO - Service d'Orthopédie A Active, not recruiting
Lille, France, 590000
Hôpital ROGER SALENGRO - Radiologie et imagerie musculo-squelettique Recruiting
Lille, France, 59000
Contact: Simon HENRY, PH       simon.henry@chru-lille.fr   
Hôpital ROGER SALENGRO - Rhumatologie Recruiting
Lille, France, 59000
Contact: Bernard CORTET, PUPH       bernard.cortet@chru-lille.fr   
Hôpital LAPEYRONIE - Imagerie médicale Recruiting
Montpellier, France, 34000
Contact: Catherine CYTEVAL, PUPH       c-cyteval@chu-montpellier.fr   
Hôpital LAPEYRONIE - Service Rhumatologie Recruiting
Montpellier, France, 34000
Contact: Cedric LUKAS, PH       c-lukas@chu-montpellier.fr   
CHU Nancy - Imagerie Guilloz Recruiting
Nancy, France, 54000
Contact: Alain BLUM, PUPH       alain.blum@gmail.com   
Hôpital LARIBOSISIERE - Service radiologie ostéo-articulaire Recruiting
Paris, France, 75010
Contact: Valérie BOUSSON, MD, PhD    +331 4995 6180    valerie.bousson@aphp.fr   
Hôpital LARIBOSISIERE - Service rhumatologie Recruiting
Paris, France, 75010
Contact: Philippe ORCEL, PUPH       phlippe.orcel@aphp.fr   
Hôpital COCHIN - Service radiologie B Active, not recruiting
Paris, France, 75014
Hôpital COCHIN - Service rhumatologie B Active, not recruiting
Paris, France, 75014
Hopital SUD - Service Radiologie Recruiting
Rennes, France, 35200
Contact: Raphael GUILLIN, PHA       raphael.guillin@chu-rennes.fr   
Hôpital SUD - Service rhumatologie Recruiting
Rennes, France, 35200
Contact: Pascal GUGGENBUHL, PUPH       pascal.guggenbuhl@chu-rennes.fr   
Hôpital PURPAN - Serice Radiologie Recruiting
Toulouse, France, 31000
Contact: Nicolas SANS, PUPH       sans.n@chu-toulouse.fr   
Hôpital PURPAN - Serice Rhumatologie Recruiting
Toulouse, France, 31000
Contact: Michel LAROCHE, PUPH       laroche.m@chu-toulouse.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Valérie BOUSSON, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02739555    
Other Study ID Numbers: P140909
2015-001698-41 ( EudraCT Number )
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Osteoid osteoma
Bisphophonates
Additional relevant MeSH terms:
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Osteoma
Osteoma, Osteoid
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms