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Trial · Interventional

CompletedPhase 1Registry data

Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

NCTNCT00486317 (opens ClinicalTrials.gov in a new tab)Other idSMC021A2110
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
Not stated
Sponsor
Nordic Bioscience A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
Oct 2005
Primary completion
Not stated
Completion
Not stated
First posted
14 Jun 2007 (estimated)
Last update posted
14 Jun 2007 (estimated)
Conditions
Osteoarthritis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006
  1. Ph 1

    Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

    NCT00486317

    Start Oct 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oral salmon calcitonin, salmon calcitonin nasal sprayDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of adverse events

Secondary outcomes(2)

  1. Changes in Urine CTX-I and CTX-II

  2. Changes in serum osteocalcin

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 52 Years up to 75 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
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.

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