A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

Inclusion Criteria: * Postmenopausal female, in good health (at least 5 years since last menses) * Age ≥45 and ≤70 * Weight + or - 20% of the Metropolitan Life weight table * Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL * Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range * Willing and able to comply with all study requirements * Willing and able to sign written informed consent * Negative urine pregnancy test at screening * Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse Exclusion Criteria: * History of parathyroid, thyroid, pituitary or adrenal diseases * History of musculoskeletal disease * History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders * History of cancer within 5 years of enrollment other than basal cell carcinoma * History of regular use of non-steroidal anti-inflammatory drugs (NSAID) * History of surgery within 60 days of enrollment * History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications * Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study * Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month * Presence of any clinically significant illness * Unwilling or unable to comply with all study requirements * Unwilling or unable to sign written, informed consent * History of drug or alcohol abuse * Participation in any clinical study of an investigational drug within 60 days of enrollment * Plasma CTx-1 less than 0.25 ng/mL