A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women

This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.

Inclusion Criteria

• Postmenopausal female, in good health (at least five years since last menses).
• Age greater than or equal to 45 years old and less than or equal to 70 years old
• Weight ± 20% of the Metropolitan Life weight table.
• Plasma CTx-1 greater than or equal to 0.25 ng/ml.
• Total calcium, phosphorus, and magnesium 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, 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 a Non-Steroidal Anti-inflammatory Drug (NSAID).
• History of surgery within 60 days of enrollment.
• History of hypersensitivity or allergies (other than seasonal allergies) within -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, 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.