Expired Study
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Springfield, Missouri 65802


Purpose:

The purpose of this study is to determine the effect of an oral calcitonin tablet given at night.


Criteria:

Inclusion Criteria: 1. Postmenopausal female, in good health (at least five years since last menses). 2. Age ≥ 45 and ≤ 70. 3. Weight ± 20% of the Metropolitan Life weight table. 4. Plasma CTx-1 ≥ 0.25 ng/mL. 5. Total calcium, phosphorus, and magnesium within normal range. 6. Willing and able to comply with all study requirements. 7. Willing and able to sign written informed consent. 8. Negative urine pregnancy test at screening. 9. Negative Screen for Hepatitis B and C, HIV and drugs of abuse. Exclusion Criteria: 1. History of parathyroid, thyroid, pituitary or adrenal diseases. 2. History of musculoskeletal disease. 3. History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders. 4. History of cancer within 5 years of enrollment other than basal cell carcinoma. 5. History of regular use of NSAID. 6. History of surgery within 60 days of enrollment. 7. 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. 8. Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study. 9. Use of bisphosphonates within 6 months, SERMS, estrogen or estrogen-like drugs 2 months, or calcitonin 1 month. 10. Presence of any clinically significant illness. 11. Unwilling or unable to comply with all study requirements. 12. Unwilling or unable to sign written, informed consent. 13. History of drug or alcohol abuse. 14. Participation in any clinical study of an investigational drug within 60 days of enrollment. 15. Plasma CTx-1 < 0.25 ng/mL.


NCT ID:

NCT00803686


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: October 09, 2019

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