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

A method of treating pain associated with complex regional pain syndrome comprising orally administering a dosage form to a human being in need thereof;

• wherein the dosage form is prepared by a method comprising combining 1) about 30 mg to about 200 mg of zoledronic acid with 2) an excipient, a disintegrating agent, a diluent, a binder, a lubricant, a flavoring agent, a coating, a capsule, or a combination thereof;
• wherein the dosage form is orally administered 2, 3, 4, 5, 6, 7, 8, 9, or 10 times at a frequency that is no greater than about once weekly;
• and
• no more than 500 mg of the zoledronic acid is orally administered within a period of six months;
• wherein the AUC of zoledronic acid in the human being, measured over a period of one month, is about 300 ng·h/mL to about 1000 ng·h/mL;
• wherein the human being has an average weekly pain intensity of at least 5, on the 0-10 numeric rating scale, prior to receiving the zoledronic acid;
• wherein the dosage form provides a bioavailability of zoledronic acid, when orally administered to a human being in a fasted state, of about 1% to about 3%;
• wherein the human being fasts for at least about two hours before the zoledronic acid is orally administered and for at least one hour after the zoledronic acid is orally administered;
• and
• wherein the human being remains upright for at least about one hour after the zoledronic acid is orally administered.

A method of treating pain associated with complex regional pain syndrome 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 AUC of zoledronic acid in the human being, measured over a period of one month, is about 100 ng·h/mL to about 1000 ng·h/mL;
• 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;
• wherein the human being has an average weekly pain intensity of at least 4, on the 0-10 numeric rating scale, prior to receiving zoledronic acid;
• wherein the human being fasts for at least 30 minutes 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.