Expired Study
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Springfield, Missouri 65802


Purpose:

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


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


NCT ID:

NCT00620854


Primary Contact:

Principal Investigator
Thomas Legg, D.O.
Bio-Kinetic Clinical Applications, Inc.


Backup Contact:

N/A


Location Contact:

Springfield, Missouri 65802
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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