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Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00411125
First received: December 11, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women


Condition Intervention Phase
Postmenopausal Osteoporosis
 Drug: Oral salmon calcitonin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment: 86
Study Start Date: August 2006
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Healthy postmenopausal women

Exclusion Criteria:

  • Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411125

Locations
Denmark
Copenhagen, Denmark
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Basel Novartis Basel +41 61 324 1111
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00411125     History of Changes
Other Study ID Numbers: CSMC021A2111
Study First Received: December 11, 2006
Last Updated: December 11, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Novartis:
Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
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 June 18, 2013