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A Dose Selection Study of Oral Calcitonin in Normal, Healthy, Postmenopausal Women
This study has been completed.
Sponsored by: Unigene Laboratories Inc.
Information provided by: Unigene Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00620854
  Purpose

This study compares the performance of different doses of oral salmon calcitonin.


Condition Intervention Phase
Osteoporosis
Drug: Recombinant Salmon Calcitonin
Phase II

MedlinePlus related topics: Osteoporosis
Drug Information available for: Calcitonin Calcitonin human Fortical
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Further study details as provided by Unigene Laboratories Inc.:

Primary Outcome Measures:
  • Plasma calcitonin and/or plasma bone resorption marker [ Time Frame: single dose crossover study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Recombinant Salmon Calcitonin
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 CTx-1 ≥ 0.25 ng/mL
  • Total Ca++, P, and 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, 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 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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620854

Locations
United States, Missouri
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Unigene Laboratories Inc.
Investigators
Principal Investigator: Thomas Legg, D.O. Bio-Kinetic Clinical Applications, Inc.
  More Information

Responsible Party: Unigene Laboratories, Inc. ( Dr. Kristine A. Erickson, Senior Director of Clinical Affairs )
Study ID Numbers: UGL-OR0702, Bio-Kinetic No.:96508
Study First Received: February 12, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00620854  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Calcitonin Gene-Related Peptide
Calcitonin
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Healthy
Salmon calcitonin
Bone Diseases

Additional relevant MeSH terms:
Vasodilator Agents
Therapeutic Uses
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009