Status:
COMPLETED
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
Lead Sponsor:
Tarsa Therapeutics, Inc.
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-70 years
Phase:
PHASE2
Brief Summary
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00620854
Start Date
February 1 2008
End Date
April 1 2008
Last Update
February 1 2012
Active Locations (1)
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1
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802