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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Oral Tablet; Drug: Oral Tablet; Drug: Recombinant Salmon Calcitonin (rsCT); Drug: Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rsCTA; Oral Tablet	Drug: Oral Tablet; 0.15 mgs recombinant salmon calcitonin, single oral dose; Drug: Oral Tablet; 0.2mgs recombinant salmon calcitonin, single oral tablet
Experimental: rsCTB; Oral Tablet	Drug: Oral Tablet; 0.15 mgs recombinant salmon calcitonin, single oral dose; Drug: Oral Tablet; 0.2mgs recombinant salmon calcitonin, single oral tablet
Active Comparator: Fortical; Nasal Spray	Drug: Recombinant Salmon Calcitonin (rsCT); Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.; Other Names: Fortical® nasal spray; Drug: Nasal Spray; 200 IU recombinant salmon calcitonin, single intranasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)	This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB

Collaborators and Investigators

• Sponsor: Tarsa Therapeutics, Inc.
• Investigators: Principal Investigator: Thomas Legg, D.O., Bio-Kinetic Clinical Applications, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 12, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (Estimate): February 22, 2008

Study Record Updates

• Last Update Posted (Estimate): February 1, 2012
• Last Update Submitted That Met QC Criteria: January 30, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Vasodilator Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
• Other Study ID Numbers: UGL-OR0702; Bio-Kinetic No.: 96508