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Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00486317
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : June 14, 2007
Sponsor:
Collaborator:
Novartis
Information provided by:
Nordic Bioscience A/S

Study Description
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Brief Summary:
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Oral salmon calcitonin, salmon calcitonin nasal spray Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events

Secondary Outcome Measures :
  1. Changes in Urine CTX-I and CTX-II
  2. Changes in serum osteocalcin

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

  • Any other disease or medication affecting the bone or cartilage.
  • Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00486317


Locations
Denmark
CCBR A/S
Ballerup, Denmark, 2750
Sponsors and Collaborators
Nordic Bioscience A/S
Novartis
Investigators
Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00486317     History of Changes
Other Study ID Numbers: SMC021A2110
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: June 14, 2007
Last Verified: June 2007

Keywords provided by Nordic Bioscience A/S:
Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salmon calcitonin
 Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents