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

Phase 2

Completed

Interventions: Drug: Oral Tablet
Drug: Recombinant Salmon Calcitonin (rsCT)
Drug: Nasal Spray

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
rsCTA	Oral Tablet	Oral Tablet
rsCTB	Oral Tablet	Oral Tablet
Fortical	Recombinant Salmon Calcitonin (rsCT)	Nasal Spray
Fortical	Nasal Spray	Nasal Spray

Primary Outcome Measures

Name	Time	Method
Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB	This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.

Secondary Outcome Measures