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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411125
First Posted: December 13, 2006
Last Update Posted: December 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Crossover Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411125


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00411125     History of Changes
Other Study ID Numbers: CSMC021A2111
First Submitted: December 11, 2006
First Posted: December 13, 2006
Last Update Posted: December 13, 2006
Last Verified: December 2006

Keywords provided by Novartis:
Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents