Zoledronic Acid Compared to Percutaneous Treatment in Osteoid Osteoma

NCT02739555 | Terminated Phase 3

• 2 other identifiers: P1409092015-001698-41
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 16

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.

Conditions

Osteoid Osteoma

Keywords

Osteoid osteoma; Bisphophonates

Outcome Measures

Primary Outcomes (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%.

  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).

  4 months

Secondary Outcomes (6)

• Pain

  at 1, 2, 3, 7, 10 and 16 months

• Patient'Global Impression of change (PGIC)

  at 2, 3, 7, 10 and 16 months

• Consumption of analgesic and NSAIDs

  at inclusion, 1, 2, 3, 4, 7, 10 and 16 months

• Nidus mineralization on CT scan images

  4 months

• Surface of bone marrow edema on MR images

  at 4 and 16 months

Study Arms (2)

1: Percutaneous treatment

ACTIVE COMPARATOR

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

2: Bisphosphonate treatment

EXPERIMENTAL

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

Interventions

Thermal destruction with radiofrequency or laser DEVICE

1: Percutaneous treatment

Acide Zoledronique DRUG

2: Bisphosphonate treatment

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (16)

Hopital PELLEGRIN - Service d'imagerie diagnostique et interventionnelle de l'adulte

Bordeaux, 33000, France

Location

Hopital PELLEGRIN - Service rhumatologie

Bordeaux, 33000, France

Location

Hôpital ROGER SALENGRO - Service d'Orthopédie A

Lille, 590000, France

Location

Hôpital ROGER SALENGRO - Radiologie et imagerie musculo-squelettique

Lille, 59000, France

Location

Hôpital ROGER SALENGRO - Rhumatologie

Lille, 59000, France

Location

Hôpital LAPEYRONIE - Imagerie médicale

Montpellier, 34000, France

Location

Hôpital LAPEYRONIE - Service Rhumatologie

Montpellier, 34000, France

Location

CHU Nancy - Imagerie Guilloz

Nancy, 54000, France

Location

Hôpital LARIBOSISIERE - Service radiologie ostéo-articulaire

Paris, 75010, France

Location

Hôpital LARIBOSISIERE - Service rhumatologie

Paris, 75010, France

Location

Hôpital COCHIN - Service radiologie B

Paris, 75014, France

Location

Hôpital COCHIN - Service rhumatologie B

Paris, 75014, France

Location

Hopital SUD - Service Radiologie

Rennes, 35200, France

Location

Hôpital SUD - Service rhumatologie

Rennes, 35200, France

Location

Hôpital PURPAN - Serice Radiologie

Toulouse, 31000, France

Location

Hôpital PURPAN - Serice Rhumatologie

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Osteoma, Osteoid

Interventions

Lasers

Condition Hierarchy (Ancestors)

Osteoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Valérie BOUSSON, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 15, 2016
• Study Start: June 23, 2016
• Primary Completion: April 20, 2018
• Study Completion: June 28, 2019
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)