COMPOSITIONS FOR ORAL ADMINISTRATION OF ZOLEDRONIC ACID OR RELATED COMPOUNDS FOR TREATING LOW BACK PAIN
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 low back pain comprising orally administering about 0.3 millimoles to about 2.2 millimoles of zoledronic acid within a period of two months to a human being suffering from low back pain, wherein the zoledronic acid is orally administered as 3 to 9 divided doses that are administered no more often than once a week, and wherein the human being experiences pain relief that lasts for a duration of at least 3 days.
2 . The method of claim 1 , wherein 0.15 millimoles to 0.22 millimoles of zoledronic acid is administered once weekly.
3 . The method of claim 1 , wherein about 0.18 millimoles of zoledronic acid is administered once weekly.
4 . The method of claim 1 , wherein the zoledronic acid is orally administered once weekly for 6 weeks.
5 . The method of claim 2 , wherein the zoledronic acid is orally administered once weekly for 6 weeks.
6 . The method of claim 3 , wherein the zoledronic acid is orally administered once weekly for 6 weeks.
7 . The method of claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously.
8 . The method of claim 2 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously.
9 . The method of claim 3 , wherein the zoledronic acid is orally administered in a manner that results in a 24 hour sustained plasma level factor that is at least 1.5 times that of 4 mg of zoledronic acid administered intravenously.
10 . The method of claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
11 . The method of claim 2 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
12 . The method of claim 3 , wherein the zoledronic acid is orally administered in a manner that results in a 48 hour sustained plasma level factor that is at least twice that of 4 mg of zoledronic acid administered intravenously.
13 . The method of claim 1 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is at least 1.1%.
14 . The method of claim 2 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is at least 1.1%.
15 . The method of claim 3 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is at least 1.1%.
16 . The method of claim 1 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.3% to 4%.
17 . The method of claim 2 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.3% to 4%.
18 . The method of claim 3 , wherein zoledronic acid is orally administered in a manner that results in a bioavailability that is 1.3% to 4%.
19 . The method of claim 1 , wherein the human being is not suffering from cancer.
20 . The method of claim 2 , wherein the human being is not suffering from cancer.
21 . The method of claim 3 , wherein the human being is not suffering from cancer.
22 . The method of claim 1 , wherein the zoledronic acid is administered in an oral dosage form that is at least 10% zoledronic acid by weight.
23 . The method of claim 2 , wherein the zoledronic acid is administered in an oral dosage form that is at least 10% zoledronic acid by weight.
24 . The method of claim 3 , wherein the zoledronic acid is administered in an oral dosage form that is at least 10% zoledronic acid by weight.
25 . The method of claim 1 , wherein the zoledronic acid is orally administered in a manner that results in a plasma concentration of zoledronic acid at 72 hours after zoledronic acid is orally administered that is about 0.1 ng/mL to about 0.6 ng/mL.
26 . The method of claim 2 , wherein the zoledronic acid is orally administered in a manner that results in a plasma concentration of zoledronic acid at 72 hours after zoledronic acid is orally administered that is about 0.1 ng/mL to about 0.6 ng/mL.
27 . The method of claim 3 , wherein the zoledronic acid is orally administered in a manner that results in a plasma concentration of zoledronic acid at 72 hours after zoledronic acid is orally administered that is about 0.1 ng/mL to about 0.6 ng/mL.
28 . The method of claim 1 , wherein the human being is fasted for at least 30 minutes after zoledronic acid is orally administered.
29 . The method of claim 2 , wherein the human being is fasted for at least 30 minutes after zoledronic acid is orally administered.
30 . The method of claim 3 , wherein the human being is fasted for at least 30 minutes after zoledronic acid is orally administered.