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Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

NCT00486317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2007-06-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Oral salmon calcitonin, salmon calcitonin nasal spray

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Nordic Bioscience A/S

    lead INDUSTRY

Principal Investigators

  • Bente J Riis, M.D. · Nordic Bioscience A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
52 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486317 on ClinicalTrials.gov