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

1. A method of treating pain associated with complex regional pain syndrome comprising orally administering a dosage form containing zoledronic acid to a human being suffering from complex regional pain syndrome associated with an inciting injury;

wherein the dosage form is administered 1, 2, 3, or 4 times within a period of about one month;

wherein about 300 mg to about 500 mg of the zoledronic acid is administered within the period of about one month;

wherein the AUC of zoledronic acid in the human being, measured over the period of about one month, is about 200 ng·h/mL to about 1000 ng·h/mL;

wherein the human being has an average weekly pain intensity of at least 4, on the 0-10 numeric rating scale, prior to receiving the zoledronic acid;

wherein the dosage form provides a bioavailability of zoledronic acid of about 1.1% to about 1.5%;

wherein the human being fasts for at least 4 hours before the zoledronic acid is orally administered and for at least 30 minutes after the zoledronic acid is orally administered; and

wherein the human being remains upright for at least about 30 minutes after the zoledronic acid is orally administered.

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 orally administered in at least 2 consecutive doses that are at least about 1 week apart.

5. The method of claim 1 , wherein the AUC of zoledronic acid in the human being, measured over a period of one month, is about 200 ng·h/mL to about 500 ng·h/mL.

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 500 ng·h/mL to about 1000 ng·h/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·h/mL to about 700 ng·h/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 700 ng·h/mL to about 1000 ng·h/mL.

9. The method of claim 1 , wherein orally administering zoledronic acid in an acid form or a salt form to the human being results in a C max of zoledronic acid of at least about 30 ng/mL.

10. The method of claim 1 , wherein orally administering zoledronic acid in an acid form or a salt form to the human being results in a C max of zoledronic acid of at least about 50 ng/mL.

11. The method of claim 1 , 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.

12. The method of claim 1 , wherein, at the beginning of treatment, the human being has an average weekly pain intensity of at least 7 on the 0-10 numeric rating scale.

13. The method of claim 1 , wherein, at the beginning of treatment, the human being has an average weekly pain intensity of at least 8 on the 0-10 numeric rating scale.

14. The method of claim 1 , wherein the dosage form containing zoledronic acid is first administered at least one month after the inciting injury.

15. The method of claim 1 , wherein the human being has suffered from complex regional pain syndrome for at least 3 months prior to receiving the dosage form containing zoledronic acid.

16. The method of claim 1 , wherein the human being has suffered from complex regional pain syndrome for at least 6 months prior to receiving the dosage form containing zoledronic acid.

17. The method of claim 1 , wherein the human being has at least a 50% reduction in CTx serum levels.

18. The method of claim 1 , wherein the dosage form further comprises a lysine.

19. The method of claim 1 , wherein the human being has a reduction in pain intensity of at least about 1 on the 0-10 numeric rating scale as compared to immediately prior to the first administration of the dosage form containing zoledronic acid.

20. The method of claim 1 , wherein the human being has a reduction in pain intensity of at least about 1.5 on the 0-10 numeric rating scale as compared to immediately prior to the first administration of the dosage form containing zoledronic acid.

21. The method of claim 1 , wherein the dosage form contains about 90 mg/m 2 to about 100 mg/m 2 of zoledronic acid.

22. The method of claim 1 , wherein the dosage form contains about 160 mg of zoledronic acid.

23. The method of claim 3 , wherein the dosage form contains about 90 mg/m 2 to about 100 mg/m 2 of zoledronic acid.

24. The method of claim 3 , wherein the dosage form contains about 160 mg of zoledronic acid.

25. The method of claim 3 , wherein the dosage form contains about 1.5 mg/kg to about 3.5 mg/kg of zoledronic acid.

26. The method of claim 1 , wherein the dosage form contains at least about 20% zoledronic acid, based upon the weight of the diacid form with respect to the total weight of the dosage form.

27. The method of claim 1 , wherein the human being experiences a reduction in edema as compared to immediately prior to the first administration of the dosage form containing zoledronic acid.

28. The method of claim 1 , wherein the human being experiences a reduction in edema that is at least about 60% as compared to immediately prior to the first administration of the dosage form containing zoledronic acid.

29. The method of claim 1 , wherein administration of the dosage form to the human being results in a T max of zoledronic acid of about 1 hour or less.

30. The method of claim 1 , wherein the dosage form is an enteric coated solid dosage form.