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

Completed · Phase 2

Conditions studied: Osteoporosis

In brief

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

Key facts

Study ID

NCT00620854

Run by

Tarsa Therapeutics, Inc.

People needed

24

Starts

2008-02-01

Expected to finish

2008-04-01

Last updated by the study team

2012-02-01

Who can join

Age: 45 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bio-Kinetic Clinical Applications, Inc. — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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