A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Recombinant Salmon Calcitonin (rsCT); Oral Tablet; Oral Tablet; Nasal Spray
Intervention description: Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.; 0.15 mgs recombinant salmon calcitonin, single oral dose; 0.2mgs recombinant salmon calcitonin, single oral tablet; 200 IU recombinant salmon calcitonin, single intranasal spray
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study compares the performance of different doses of oral recombinant salmon calcitonin
      (rsCT).
    

Eligibility criteria:

        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