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

Sponsor:	Tarsa Therapeutics, Inc.
Information provided by (Responsible Party):	Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00620854

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: Recombinant Salmon Calcitonin (rsCT) Drug: Oral Tablet Drug: Nasal Spray	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

Further study details as provided by Tarsa Therapeutics, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

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
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

Eligibility

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 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

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

Tarsa Therapeutics, Inc.

Investigators

Principal Investigator:

Thomas Legg, D.O.

Bio-Kinetic Clinical Applications, Inc.

More Information

No publications provided

Responsible Party:	Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00620854 History of Changes
Other Study ID Numbers:	UGL-OR0702, Bio-Kinetic No.: 96508
Study First Received:	February 12, 2008
Results First Received:	April 22, 2009
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide

Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012