A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
NCT ID: NCT00620854
Last Updated: 2012-02-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2008-02-29
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
NCT01292187
A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women
NCT00959764
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
NCT00239889
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women
NCT00372099
A Study of the Treatment of Postmenopausal Women With Osteoporosis
NCT00543023
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rsCTA
Oral Tablet
Oral Tablet
0.15 mgs recombinant salmon calcitonin, single oral dose
rsCTB
Oral Tablet
Oral Tablet
0.2mgs recombinant salmon calcitonin, single oral tablet
Fortical
Nasal Spray
Recombinant Salmon Calcitonin (rsCT)
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
Nasal Spray
200 IU recombinant salmon calcitonin, single intranasal spray
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
45 Years
70 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tarsa Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Legg, D.O.
Role: PRINCIPAL_INVESTIGATOR
Bio-Kinetic Clinical Applications, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Bio-Kinetic No.: 96508
Identifier Type: -
Identifier Source: secondary_id
UGL-OR0702
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.