Last updated: March 11, 2024
Sponsor: University Hospital, Limoges
Overall Status: Active - Recruiting
Phase
2
Condition
Bone Diseases
Musculoskeletal Diseases
Bone Neoplasm
Treatment
Pentoxifylline+Tocopherol
Clinical Study ID
NCT05795647
87RI21_0052 (PENTO)
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age greater than or equal to 18 years
- Current or past treatment with bisphosphonates (oral or IV) and/or targeted therapies (denosumab, bevacizumab)
- Signs and symptoms for more than 8S with confirmation that the signs and symptoms arenot of dental origin
- AAOMS Stage 2 MRONJ
- For patients of childbearing age, effective contraception is required
Exclusion
Exclusion Criteria:
- History of head or neck radiotherapy or maxilla metastases
- Patients who have received treatment in the past (PENTO or PENTOCLO protocol)
- Patients who have undergone surgery for their MRONJ within the last 3 months
- Pregnant or wishing to be pregnant, breastfeeding
- Patient under palliative care
- Patient with hypersensitivity to pentoxifylline or tocopherol or to an excipient
- History of hypersensitivity reaction to penicillins, cephalosporins, or otherbeta-lactams (and clindamycin or lincomycin if applicable) or excipient ofamoxicillin-a. clavulanic or clindamycin
- History of jaundice/hepatic injury related to amoxicillin/clavulanic acid
- Patient taking oral anticoagulants, or with a history of major bleeding or bleedingdisorders
- Patient taking platelet aggregation inhibitor, theophylline or aminophylline
- Patient taking methotrexate, probenecid, mycophenolate mofetil, myorelaxant drugs,macrolide or streptogramin antibiotics
- Patients with hepatic failure or renal failure (Cl < 30 mL/min),
- Patient with hypotension (SBP < 90 mmHg)
- Refusal to participate in the study
- Patient participating in other interventional research that may interfere with theconduct of this research
- Patient unable to understand the protocol
- Patient under curatorship or guardianship
Study Design
Total Participants: 17
Treatment Group(s): 1
Primary Treatment: Pentoxifylline+Tocopherol
Phase: 2
Study Start date:
February 29, 2024
Estimated Completion Date:
April 07, 2025
Study Description
Connect with a study center
Limoges university hospital
Limoges, 87042
FranceActive - Recruiting
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