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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620854
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : September 24, 2009
Last Update Posted : February 1, 2012
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Recombinant Salmon Calcitonin (rsCT) Drug: Oral Tablet Drug: Nasal Spray Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: rsCTA
Oral Tablet
Drug: Oral Tablet
0.15 mgs recombinant salmon calcitonin, single oral dose

Experimental: rsCTB
Oral Tablet
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 Name: Fortical® nasal spray

Drug: Nasal Spray
200 IU recombinant salmon calcitonin, single intranasal spray

Primary Outcome Measures :
  1. Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) [ Time Frame: 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620854

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United States, Missouri
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Tarsa Therapeutics, Inc.
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Principal Investigator: Thomas Legg, D.O. Bio-Kinetic Clinical Applications, Inc.
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Responsible Party: Tarsa Therapeutics, Inc. Identifier: NCT00620854    
Other Study ID Numbers: UGL-OR0702
Bio-Kinetic No.: 96508
First Posted: February 22, 2008    Key Record Dates
Results First Posted: September 24, 2009
Last Update Posted: February 1, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Salmon calcitonin
Calcitonin Gene-Related Peptide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents