COMPOSITION FOR ORAL ADMINISTRATION OF ZOLEDRONIC ACID OR RELATED COMPOUNDS FOR TREATING COMPLEX REGIONAL PAIN SYNDROME
Oral dosage forms of osteoclast inhibitors, such as nitrogen-containing bisphosphonates, such as zoledronic acid, can be used to treat or alleviate pain or related conditions.
1 . A method of treating chronic 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 200 mg to about 300 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·h/mL to about 500 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 1000 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 500 ng·h/mL to about 700 ng·h/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·h/mL to about 1000 ng·h/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 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 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 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 1 Modic change.
30 . The method of claim 16 , wherein the human being is at least 40 years of age.