Compositions for oral administration of zoledronic acid or related compounds for treating complex regional pain syndrome

Abstract

Oral dosage forms of bisphosphonate compounds, such as zoledronic acid, can be used to treat or alleviate pain or related conditions. The oral bioavailability of zoledronic acid can be enhanced by administering the zoledronic acid in the disodium salt form

1 . A method of treating complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being receives a total of about 100 mg to about 350 mg zoledronic acid in at least two divided doses that are orally administered within a period of six months, and wherein the human being has suffered a traumatic event to incite the complex regional pain syndrome. 
     
     
         2 . The method of  claim 1 , wherein zoledronic acid is orally administered within a period of one or two months. 
     
     
         3 . The method of  claim 1 , wherein the human being receives at least three doses of zoledronic acid. 
     
     
         4 . The method of  claim 3 , wherein the zoledronic acid is orally administered three to five times a month. 
     
     
         5 . The method of  claim 1 , wherein the human being receives at least six doses of zoledronic acid. 
     
     
         6 . The method of  claim 5 , wherein the zoledronic acid is not administered more frequently than weekly. 
     
     
         7 . The method of  claim 1 , wherein three doses for a total amount of at least about 125 mg of zoledronic acid are orally administered within a period of two months. 
     
     
         8 . A method of treating pain associated with complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being receives at least two divided doses of about 20 mg to about 100 mg per dose of zoledronic acid and no more than a total amount of about 500 mg of zoledronic acid within a period of six months, and wherein the human being has suffered a traumatic event to precipitate the complex regional pain syndrome. 
     
     
         9 . The method of  claim 8 , wherein the human being receives two doses to eight doses of zoledronic acid within a period of four months. 
     
     
         10 . The method of  claim 9 , wherein each dose comprises about 20 mg to about 60 mg of zoledronic acid. 
     
     
         11 . The method of  claim 9 , wherein each dose comprises about 35 mg to about 60 mg of zoledronic acid. 
     
     
         12 . The method of  claim 8 , wherein the human being experiences pain relief for at least 48 hours. 
     
     
         13 . The method of  claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma factor that is at least twice that of 1 mg of zoledronic acid administered intravenously. 
     
     
         14 . The method of  claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma factor that is at least twice that of a sustained plasma factor of 4 mg of zoledronic acid administered intravenously. 
     
     
         15 . The method of  claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma factor that is at least 1.2 times that of 4 mg of zoledronic acid administered intravenously. 
     
     
         16 . The method of  claim 8 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma factor that is at least twice that of 4 mg of zoledronic acid administered intravenously. 
     
     
         17 . A method of treating complex regional pain syndrome comprising orally administering zoledronic acid to a human being in need thereof, wherein the human being has suffered a traumatic event to precipitate the complex regional pain syndrome. 
     
     
         18 . The method of  claim 17 , wherein the human being receives about 100 mg to about 400 mg of zoledronic acid within a period of six months. 
     
     
         19 . The method of  claim 17 , wherein the human being experiences at least 48 hours of pain relief. 
     
     
         20 . The method of  claim 17 , wherein the human being fasts for at least 30 minutes after the zoledronic acid is orally administered. 
     
     
         21 . The method of  claim 17 , wherein the human being fasts for at least 30 minutes before the zoledronic acid is orally administered. 
     
     
         22 . The method of  claim 18 , wherein zoledronic acid is orally administered for one to three months. 
     
     
         23 . The method of  claim 17 , wherein the zoledronic acid is orally administered weekly. 
     
     
         24 . The method of  claim 18 , wherein the zoledronic acid is orally administered weekly for one to two months. 
     
     
         25 . The method of  claim 24 , wherein at least 100 mg zoledronic acid is orally administered within the first month of treatment. 
     
     
         26 . The method of  claim 23 , wherein the zoledronic acid is orally administered two to four times in one month. 
     
     
         27 . The method of  claim 26 , wherein about 10 mg to about 100 mg of zoledronic acid is orally administered in a weekly dose. 
     
     
         28 . The method of  claim 23 , wherein the zoledronic acid is orally administered for two to eight times in two months. 
     
     
         29 . The method of  claim 28 , wherein about 10 mg to about 100 mg of zoledronic acid is orally administered in a weekly dose. 
     
     
         30 . The method of  claim 17 , wherein the zoledronic acid is orally administered in a dosage form containing at least 30% zoledronic acid.