EFFICACY AND SAFETY OF NERIDRONATE IN BONE EDEMA SYNDROME

Background: Bone Marrow Edema Syndrome (BMES) is a severely disabling pain syndrome without a definite treatment and refers to transient clinical conditions with unknown pathogenic mechanism, such as transient osteoporosis of the hip (TOH), regional migratory osteoporosis (RMO), and reflex sympathetic dystrophy (RSD). Magnetic resonance imaging is used for the early diagnosis and monitoring the progression of the disease. Early differentiation from other aggressive conditions with long-term sequelae is essential in order to avoid unnecessary treatment. Objectives: Aim of this monocentric trial was to test the efficacy and the safety of the amino-bisphosphonate neridronate in patients with BMES administered in two different regimens. Methods: 192 patients with BMES secondary to osteoarthritis localized to knee, hip, wrist or foot were randomly assigned to I.V. infusion of 100 mg neridronate given four times over 10 days (Group A, 72 subjects) or alternatively to I.V. infusions of 100 mg every 21 days over 3 months (Group B, 120 subjects). At baseline and after 180 days we performed an MRI. We assessed a 0-100 mm pain VAS in each patient, too. Outcomes were to evaluate the MRI changes and the VAS changes. A control group (35 patients) was enrolled too, treated conservatively with NSAIDs and articular rest. Results: we observed a significant improvement in MRI with the resolution of bone marrow lesions present at the baseline (p 0.1). Both groups showed a significant clinical and radiologic improvement compared with control group (p Conclusion: In 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 BMES. Disclosure of Interests: : None declared