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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Recombinant Salmon Calcitonin (rsCT)

Oral Tablet

Nasal Spray

About this trial

This is an interventional basic science trial for Osteoporosis

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Bio-Kinetic Clinical Applications, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

rsCTA

rsCTB

Fortical

Arm Description

Oral Tablet

Nasal Spray

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00620854

First Posted

February 12, 2008

Last Updated

January 30, 2012

Sponsor

Tarsa Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00620854

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tarsa Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rsCTA

Arm Type

Experimental

Arm Description

Oral Tablet

Arm Title

rsCTB

Arm Type

Experimental

Arm Description

Oral Tablet

Arm Title

Fortical

Arm Type

Active Comparator

Arm Description

Nasal Spray

Intervention Type

Drug

Intervention Name(s)

Recombinant Salmon Calcitonin (rsCT)

Other Intervention Name(s)

Fortical® nasal spray

Intervention Description

Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.

Intervention Type

Drug

Intervention Name(s)

Oral Tablet

Intervention Description

0.15 mgs recombinant salmon calcitonin, single oral dose

Intervention Type

Drug

Intervention Name(s)

Oral Tablet

Intervention Description

0.2mgs recombinant salmon calcitonin, single oral tablet

Intervention Type

Drug

Intervention Name(s)

Nasal Spray

Intervention Description

200 IU recombinant salmon calcitonin, single intranasal spray

Primary Outcome Measure Information:

Title

Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Legg, D.O.

Organizational Affiliation

Bio-Kinetic Clinical Applications, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bio-Kinetic Clinical Applications, Inc.

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65802

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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