Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

Nordic Bioscience A/S

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Osteoarthritis

Interventions

Oral salmon calcitonin, salmon calcitonin nasal sprayDRUG

Eligibility

Sex: ALLMin age: 52 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

CCBR A/S

Ballerup Municipality, Denmark

Outcomes

Primary Outcomes

Number of adverse events

Secondary Outcomes

Changes in Urine CTX-I and CTX-II

Changes in serum osteocalcin

Data from ClinicalTrials.gov

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