Osteoarthritis
Conditions
Keywords
Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers
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.
Interventions
Sponsors
Novartis
Nordic Bioscience A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
52 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Urine CTX-I and CTX-II | — |
| Changes in serum osteocalcin | — |
Countries
Denmark
Outcome results
None listed