Status:
UNKNOWN
Best Treatment Choice for Osteonecrosis of the Jaw
Lead Sponsor:
Tim Van den Wyngaert
Collaborating Sponsors:
Kom Op Tegen Kanker
Conditions:
Medication Related Osteonecrosis of the Jaw
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
BETCON is a pragmatic randomized controlled open-label multi-center study in patients with newly diagnosed stage I-II MRONJ designed to answer the question whether minimally invasive management with L...
Detailed Description
While effective for symptom control and well tolerated, conservative treatment of MRONJ yields highly variable mucosal healing rates ranging between 20 to 50%. In an effort to improve these suboptimal...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \>18 years of age
- Provision of signed informed consent
- A history of at least one administration of, or an ongoing treatment with, a bone modifying agent in dose registered for the prevention of skeletal related events in bone metastatic disease or multiple myeloma
- Diagnosis of stage I-II MRONJ according to AAOMS 2014 criteria not more than 8 weeks prior to the date of screening
- Exclusion criteria:
- Any prior treatment for MRONJ other than local antiseptic rinses, systemic antibiotics, or analgesics
- Prior radiotherapy to the head and neck region
- Medical contraindication to receive any of the possible study treatments
- Stage III MRONJ characterized by very extensive bone necrosis, pathological fracture, or fistulas to the skin or sinuses
- Multiple MRONJ lesions that cannot be closed in a single surgical procedure
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04512638
Start Date
January 1 2021
End Date
January 1 2026
Last Update
May 23 2023
Active Locations (4)
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1
ZNA Middelheim
Antwerp, Belgium, 2020
2
Antwerp University Hospital
Edegem, Belgium, 2650
3
UZ Leuven
Leuven, Belgium, 3000
4
AZ Nikolaas
Sint-Niklaas, Belgium, 9100