24
Participants
Start Date
January 16, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
modified PENTOCLO (mPENTOCLO)
"4-week pre-treatment phase consisting of 2 g daily of Amoxicillin+Clavulanic acid 875/125 mg (1 g morning and night), 1 g ciprofloxacin (500 mg morning and night) and 50 mg Fluconazole daily (morning), taken orally by the patient.~This is followed by an additional 11 months (12 months total) treatment phase consisting of 800 mg pentoxifylline (400 mg morning and night) and 800 IU tocopherol (400 IU morning and night) taken orally 5 days per week (Monday to Friday with no medications on Saturday and Sunday). If the patient deteriorates (i.e., worsening of ORN T 6 or 9-month follow-up) then clodronate 1600 mg once daily (Monday to Friday) for the rest of the study period will be added."
sham mPENTOCLO
"4-week pre-treatment phase consisting of 2 g daily of Amoxicillin+Clavulanic acid 875/125 mg (1 g morning and night), 1 g ciprofloxacin (500 mg morning and night) and 50 mg Fluconazole daily (morning), taken orally by the patient.~This is followed by an additional 11 months (12 months total) of sham treatment phase (placebo)."
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
Sunnybrook Health Sciences Centre
OTHER