Oral dosage forms of a bisphosphonate comprised of a safe and effective
amount of a pharmaceutical composition comprising a bisphosphonate, a
chelating agent, and, means for effecting delayed release of the
bisphosphonate and the chelating agent in the lower gastrointestinal
tract provide delivery of the pharmaceutical composition to the lower
gastrointestinal tract of the mammal subject and pharmaceutically
effective absorption of the bisphosphonate with or without food or
beverages. The present invention substantially alleviates the interaction
between bisphosphonates and food or beverages, which interaction results
in the bisphosphonate active ingredient not being available for
absorption. The resulting oral dosage form may thus be taken with or
without food. Further, the present invention effects delivery of the
bisphosphonate and the chelating agent to the lower GI tract,
substantially alleviating the upper GI irritation associated with
bisphosphonate therapies. These benefits simplify previously complex
treatment regimens and can lead to increased patient compliance with
bisphosphonate therapies.