Back to resultsPharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Oral salmon calcitonin
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin
Eligibility Criteria
Inclusion Criteria:
- Healthy postmenopausal women
Exclusion Criteria:
- Previous treatment with other osteoporosis medication
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Effect on bone resorption biomarker on Day 1
Secondary Outcome Measures
Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
Effect on bone resorption biomarker after drug intake at different timepoints
Effect of dosing at different timepoints on the pharmacokinetic profile
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00411125
Brief Title
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Official Title
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
86 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral salmon calcitonin
Primary Outcome Measure Information:
Title
Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Title
Effect on bone resorption biomarker on Day 1
Secondary Outcome Measure Information:
Title
Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
Title
Effect on bone resorption biomarker after drug intake at different timepoints
Title
Effect of dosing at different timepoints on the pharmacokinetic profile
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Healthy postmenopausal women
Exclusion Criteria:
Previous treatment with other osteoporosis medication
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Basel
Organizational Affiliation
Novartis Basel +41 61 324 1111
Official's Role
Study Director
Facility Information:
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19055791
Citation
Karsdal MA, Byrjalsen I, Riis BJ, Christiansen C. Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin. BMC Clin Pharmacol. 2008 Dec 4;8:12. doi: 10.1186/1472-6904-8-12.
Results Reference
derived
Learn more about this trial
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women
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