Status:
COMPLETED
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
Lead Sponsor:
Tarsa Therapeutics, Inc.
Conditions:
Phase 1 Pharmacodynamic Study
Eligibility:
FEMALE
45-70 years
Phase:
PHASE2
Brief Summary
This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available ...
Detailed Description
Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective th...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Postmenopausal female, in good health (at least five years since last menses).
- Age greater than or equal to 45 years old and less than or equal to 70 years old
- Weight ± 20% of the Metropolitan Life weight table.
- Plasma CTx-1 greater than or equal to 0.25 ng/ml.
- Total calcium, phosphorus, and magnesium 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, 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 a Non-Steroidal Anti-inflammatory Drug (NSAID).
- History of surgery within 60 days of enrollment.
- History of hypersensitivity or allergies (other than seasonal allergies) within -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, 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.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00803686
Start Date
December 1 2008
End Date
January 1 2009
Last Update
June 9 2014
Active Locations (1)
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1
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802