Use of neridronic acid or of its salt for the treatment of osteoarthrosis

Abstract

The use of neridronic acid or a salt thereof in the treatment of osteoarthritis is described. In particular, neridronic acid or a salt thereof has been shown to be able to reduce significantly the symptoms of osteoarthritis, such as pain and physical and mobility disabilities, as well as subchondral bone marrow lesions underlying the onset of such symptoms.

1 . A method of treating osteoarthritis comprising administering a therapeutically effective amount of neridronic acid or a salt thereof to patients in need thereofs. 
     
     
         2 . The method of  claim 1 , wherein the treatment of osteoarthritis comprises alleviating the pain symptomathology of joint pain. 
     
     
         3 . The method of  claim 1 , wherein the treatment of osteoarthritis comprises alleviating joint stiffness and improving mobility and physical functionality. 
     
     
         4 . The method of  claim 1 , wherein the treatment of osteoarthritis comprises reducing the size and extent of bone marrow lesions. 
     
     
         5 . The method of  claim 1 , wherein said salt of neridronic acid is sodium neridronate. 
     
     
         6 . The method of  claim 1 , wherein said neridronic acid or a salt thereof is to be administered at a dosage of 10-500 mg. 
     
     
         7 . The method of  claim 1 , wherein said neridronic acid or a salt thereof is to be administered orally, intramuscularly, intravenously, intraarticularly, transdermally, subcutaneously or topically. 
     
     
         8 . The method of  claim 7 , wherein said neridronic acid or a salt thereof is to be administered intravenously. 
     
     
         9 . The method of  claim 8 , wherein said neridronic acid or a salt thereof is to be administered intravenously at a dosage of 25-400 mg, at least 2 times, with at least 1 day between an administration and a subsequent one. 
     
     
         10 - 14 . (canceled) 
     
     
         15 . The method of  claim 9 , wherein said salt of neridronic acid is sodium neridronate to be administered intravenously at a dosage equivalent to 100 mg of neridronic acid, 4 times over a period of 10 days, with 3 days between an administration and a subsequent one. 
     
     
         16 . The method of  claim 15 , wherein sodium neridronate is to be administered intravenously on days 1, 4, 7 and 10. 
     
     
         17 . The method of  claim 1  comprising administering a therapeutically effective amount of a pharmaceutical composition comprising neridronic acid or a salt thereof, and pharmaceutically acceptable vehicles for the oral, intramuscular, intravenous, intra-articular, transdermal, sub-cutaneous or topical administration. 
     
     
         18 . The method of  claim 17 , wherein said pharmaceutical composition is administered intravenously, and comprises sodium neridronate, sodium chloride, citric acid and sodium citrate or sodium neridronate, sodium chloride and sodium bicarbonate . 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 16  wherein said pharmaceutical composition is present as a unit dose comprising 1-10 ml of aqueous solution in a vial or bottle, said unit dose preferably comprising 70-150 mg of neridronic acid or a salt thereof. 
     
     
         21 . The method of  claim 1  wherein said therapeutically effective amount of neridronic acid or salt thereof is administered by a vial or bottle for intravenous administration comprising neridronic acid or a salt thereof. 
     
     
         22 . The method of  claim 21  wherein said vial or bottle comprises a unit dose of 70-150 mg of neridronic acid or a salt thereof. 
     
     
         23 . The method of  claim 22  wherein said vial or bottle comprises 100 mg of neridronic acid or a salt thereof in an amount equivalent to 100 mg of neridronic acid. 
     
     
         24 . The method of  claim 21 , wherein said salt of neridronic acid is sodium neridronate. 
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 7 , wherein said neridronic acid or a salt thereof is administered intramuscularly. 
     
     
         27 . The method of  claim 26 , wherein said neridronic acid or a salt thereof is administered intramuscularly at a dosage of 10-100 mg. 
     
     
         28 . The method of  claim 27 , wherein said salt of neridronic acid is sodium neridronate to be administered intramuscularly at a dosage equivalent to 25 mg of neridronic acid. 
     
     
         29 . (canceled)