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A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women | Clinical Trials | Clareo Health

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

NCT00620854•Tarsa Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

45 - 70 years

Sex

FEMALE

Healthy Volunteers

Yes

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
+5 more criteria

Locations (1)

Bio-Kinetic Clinical Applications, Inc.

Springfield, Missouri, United States

Key Dates

Start Date

February 1, 2008

Primary Completion Date

April 1, 2008

Completion Date

April 1, 2008

Last Updated

February 1, 2012

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

Recombinant Salmon Calcitonin (rsCT)

DRUG

Oral Tablet

DRUG

Oral Tablet

DRUG

Nasal Spray

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

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