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Trial record 30 of 247 for:    CALCITONIN SALMON

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

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. Identifier: NCT00411125
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : December 13, 2006
Information provided by:

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

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Oral salmon calcitonin Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 86 participants
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
Study Start Date : August 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. Pharmacokinetic profile of the new variant compared to the current variant on Day 1
  2. Effect on bone resorption biomarker on Day 1

Secondary Outcome Measures :
  1. Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
  2. Effect on bone resorption biomarker after drug intake at different timepoints
  3. Effect of dosing at different timepoints on the pharmacokinetic profile

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female

Inclusion Criteria:

  • Healthy postmenopausal women

Exclusion Criteria:

  • Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

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 identifier (NCT number): NCT00411125

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00411125    
Other Study ID Numbers: CSMC021A2111
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: December 13, 2006
Last Verified: December 2006
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Salmon calcitonin
Calcitonin Gene-Related Peptide
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents