Compositions for administration of zoledronic acid or related compounds for treating low back pain

Abstract

Oral dosage forms of osteoclast inhibitors, such as zoledronic acid in an acid or a salt form, can be used to treat or alleviate pain or related conditions, such as low back pain.

What is claimed is: 
     
         1 . A method of treating low back pain, comprising orally administering zoledronic acid in a disodium salt form to a human being in need thereof, wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in an AUC of zoledronic acid, over a four week period, that is about 100 ng·h/mL to about 1000 ng·h/mL. 
     
     
         2 . The method of  claim 1 , wherein each orally administered dose contains about 50 mg to about 60 mg of the zoledronic acid in the disodium salt form. 
     
     
         3 . The method of  claim 1 , wherein the zoledronic acid in the disodium salt form is orally administered at an interval of about 5 to 10 days. 
     
     
         4 . The method of  claim 2 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week. 
     
     
         5 . The method of  claim 1 , wherein each orally administered dose of the zoledronic acid in the disodium salt form is administered in a manner that provides an AUC of zoledronic acid of about 140 ng·h/mL to about 150 ng·h/mL, measured over a 24 hour period. 
     
     
         6 . The method of  claim 4 , wherein each orally administered dose of the zoledronic acid in the disodium salt form is administered in a manner that provides an AUC of zoledronic acid of about 130 ng·h/mL to about 150 ng·h/mL, measured over a 24 hour period. 
     
     
         7 . The method of  claim 1 , wherein the low back pain is associated with a Modic change. 
     
     
         8 . The method of  claim 6 , wherein the low back pain is associated with a Modic change. 
     
     
         9 . The method of  claim 1 , wherein the zoledronic acid in a disodium salt form is orally administered in a dosage form that contains no external agents which enhance the bioavailability of zoledronic acid. 
     
     
         10 . A method of treating low back pain, comprising orally administering zoledronic acid in a disodium salt form to a human being in need thereof, wherein the zoledronic acid in the disodium salt form is orally administered in a manner that results in an AUC of zoledronic acid that is about 100 ng·h/mL to about 500 ng·h/mL, measured over a 24 hour period, each time the zoledronic acid in the disodium salt form is administered. 
     
     
         11 . The method of  claim 10 , wherein the zoledronic acid in the disodium salt form is orally administered in an amount that results in an AUC of zoledronic acid that is about 100 ng·h/mL to about 160 ng·h/mL, measured over a 24 hour period, each time the zoledronic acid in the disodium salt form is administered. 
     
     
         12 . The method of  claim 10 , wherein about 50 mg to about 70 mg of the zoledronic acid in the disodium salt form is orally administered weekly. 
     
     
         13 . The method of  claim 10 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week for about six weeks. 
     
     
         14 . The method of  claim 12 , wherein the zoledronic acid in the disodium salt form is orally administered about once a week for about six weeks. 
     
     
         15 . The method of  claim 10 , wherein the low back pain is associated with a Modic change. 
     
     
         16 . The method of  claim 10 , wherein the zoledronic acid in a disodium salt form is orally administered in a dosage form that contains no external agents which enhance the bioavailability of zoledronic acid 
     
     
         17 . A method of treating low back pain, comprising orally administering zoledronic acid in a disodium salt form to a human being in need thereof, wherein about 100 mg to about 400 mg of the zoledronic acid in the disodium salt form is orally administered in a manner that results in a bioavailability of zoledronic acid in the human being of about 1.2% to about 3.5%. 
     
     
         18 . The method of  claim 17 , wherein the zoledronic acid in the disodium salt form is orally administered in an amount and frequency that results in a bioavailability of zoledronic acid in the human being of about 1.5% to about 2.5%. 
     
     
         19 . The method of  claim 17 , wherein the human being is not suffering from cancer or osteoporosis. 
     
     
         20 . The method of  claim 17 , wherein the human being is not suffering from multiple myeloma. 
     
     
         21 . The method of  claim 17 , wherein the human being is not suffering from bone metastases. 
     
     
         22 . The method of  claim 17 , wherein the human being is not suffering from a solid tumor. 
     
     
         23 . The method of  claim 17 , wherein the human being is not suffering from bone metastases from a solid tumor. 
     
     
         24 . The method of  claim 17 , wherein the human being is not suffering from a blood cancer. 
     
     
         25 . The method of  claim 17 , wherein the human being is not suffering from a leukemia. 
     
     
         26 . The method of  claim 17 , wherein the human being is not suffering from a giant cell tumor of bone. 
     
     
         27 . The method of  claim 17 , wherein the human being is not suffering from hypercalcemia of malignancy. 
     
     
         28 . The method of  claim 17 , wherein the zoledronic acid in a disodium salt form is orally administered in a dosage form that contains no external agents which enhance the bioavailability of zoledronic acid. 
     
     
         29 . The method of  claim 17 , wherein the zoledronic acid is orally administered in a dosage form that further comprises silicified microcrystalline cellulose, a crosslinked polyvinylpyrrolidone, a fumed silica, and magnesium stearate. 
     
     
         30 . The method of  claim 17 , wherein the low back pain is associated with a Modic change.