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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620854
• Other study ID #: UGL-OR0702
• Secondary ID: Bio-Kinetic No.:
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2008
• Last updated: January 30, 2012
• Start date: February 2008
• Est. completion date: April 2008

Study information

• Verified date: January 2012
• Source: Tarsa Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• Oral Tablet
0.15 mgs recombinant salmon calcitonin, single oral dose
• Oral Tablet
0.2mgs recombinant salmon calcitonin, single oral tablet
• Nasal Spray
200 IU recombinant salmon calcitonin, single intranasal spray

Locations

Country	Name	City	State
United States	Bio-Kinetic Clinical Applications, Inc.	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Tarsa Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No