Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

Nordic Bioscience

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis

Treatments

Drug: Oral salmon calcitonin, salmon calcitonin nasal spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT00486317

SMC021A2110

Details and patient eligibility

About

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.

Sex

All

Ages

52 to 75 years old

Volunteers

No Healthy Volunteers

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.