BackgroundBone Marrow Oedema Syndrome (BMES) is a severely disabling pain syndrome without a definite treatment well established.ObjectivesThe aim of this monocentric prospective trial was to test the efficacy and the safety of the amino-bisphosphonate neridronate in patients with BMES administered in two different schedules.Methodsone hundred seventy-three patients with BMES at various joints were consecutively assigned to I.V. infusion of 100 mg neridronate given four times over 10 days (Group A) or alternatively to I.V. infusion of 100 mg every 21 days over 63 days (Group B). At baseline (T0) and after 90 days from the first infusion we performed a MRI (T2). We assessed a 0–100 mm pain VAS in each patient at T0, at the day of the last infusion (T1: day 10 for group A and day 63 for group B) and at T2. Primary outcome was to evaluate the MRI changes, secondary endpoint was the VAS change.Resultswe observed a significant improvement in MRI with the resolution of bone marrow oedema present at T0 (p<0.01), without a significant difference between Group A and Group B. Visual analogue scale (VAS) score decreased significantly during the study in both groups (p<0.05) without a significant difference between the two treatment groups (p>0.1).ConclusionsIn patients with BMES, the infusions of neridronate 100 mg every 21 days over 3 months or alternately every 3 days over 10 days are associated with clinically relevant and persistent benefits without significant differences between the two treatment-schedules. These results provide conclusive evidence that the use of bisphosphonates, at appropriate doses, is the treatment of choice BMESDisclosure of InterestNone declared
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