Compositions for administration of zoledronic acid or related compounds for treating low back pain
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.
1. A method of treating low back pain comprising orally administering zoledronic acid to a human being in need thereof, wherein the amount of zoledronic acid orally administered to the human being within a period of about one month is about 150 mg to about 250 mg.
2. The method of claim 1 , wherein the zoledronic acid is in an acid form.
3. The method of claim 1 , wherein the zoledronic acid is in a salt form.
4. The method of claim 1 , wherein the zoledronic acid is in a disodium salt form.
5. The method of claim 1 , wherein the zoledronic acid is orally administered in at least two consecutive doses that are at least about 1 week apart.
6. The method of claim 1 , wherein the AUC of zoledronic acid in the human being, measured over a period of one month, is about 100 ng·hr/mL to about 500 ng·hr/mL.
7. The method of claim 1 , wherein the AUC of zoledronic acid in the human being, measured over a period of one month, is about 500 ng·hr/mL to about 1000 ng·hr/mL.
8. The method of claim 1 , wherein the AUC of zoledronic acid in the human being, measured over a period of one month, is about 500 ng·hr/mL to about 700 ng·hr/mL.
9. The method of claim 1 , wherein the AUC of zoledronic acid in the human being, measured over a period of one month, is about 700 ng·hr/mL to about 1000 ng·hr/mL.
10. The method of claim 1 , wherein the human being has suffered from low back pain for at least 2 months.
11. The method of claim 1 , wherein, at the beginning of treatment, the human being has an average weekly pain intensity of at least 4 on the 0-10 numeric rating scale.
12. The method of claim 1 , wherein, at the beginning of treatment, the human being has an average weekly pain intensity of at least 5 on the 0-10 numeric rating scale.
13. The method of claim 1 , wherein the low back pain is associated with a Modic change.
14. The method of claim 1 , wherein the low back pain is associated with a type 1 Modic change.
15. The method of claim 1 , wherein the low back pain is associated with a type 2 Modic change.
16. A method of treating chronic low back pain comprising orally administering a dosage form comprising zoledronic acid in an acid form or a salt form to a human being in need thereof, wherein the bioavailability of zoledronic acid in the dosage form is about 1.1% to about 1.5%, as determined when orally administered to a human being who has fasted for eight hours.
17. The method of claim 16 , wherein a single oral administration of the dosage form results in an AUC for zoledronic acid of about 130 ng·hr/mL to about 160 ng·hr/mL.
18. The method of claim 16 , wherein a single oral administration of the dosage form results in an AUC for zoledronic acid of about 300 ng·hr/mL to about 350 ng·hr/mL.
19. The method of claim 16 , wherein a single oral administration of the dosage form results in an AUC for zoledronic acid of about 405 ng·hr/mL to about 450 ng·hr/mL.
20. The method of claim 16 , wherein the dosage form contains about 100 mg to about 200 mg of the zoledronic acid based on the weight of the diacid form.
21. The method of claim 16 , wherein the dosage form is orally administered three times within a period of six months.
22. The method of claim 16 , wherein the dosage form is orally administered at an interval of about 2 weeks.
23. The method of claim 16 , wherein an amount of a non-steroidal anti-inflammatory drug that is orally administered to the human being is reduced after the dosage form comprising zoledronic acid in the acid form or the salt form is orally administered.
24. The method of claim 16 , wherein the zoledronic acid is in a salt form, wherein the imidazole ring of zoledronic acid is in an imidazolium form.
25. The method of claim 16 , wherein, at the beginning of treatment, the human being has an average weekly pain intensity of at least 5 on the 0-10 numeric rating scale.
26. The method of claim 16 , wherein, at the beginning of treatment, the human being has an average weekly pain intensity of at least 6 on the 0-10 numeric rating scale.
27. The method of claim 16 , wherein the human being has suffered from low back pain for at least 3 months.
28. The method of claim 16 , wherein the human being has a type 1 Modic change.
29. The method of claim 16 , wherein the human being has a type 2 Modic change.
30. The method of claim 16 , wherein the human being is at least 40 years of age.