NCT00486317

Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis

SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Nordic Bioscience A/S · Industry
• Sex: All
• Age: 52 Years – 75 Years
• Healthy volunteers: —

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

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Oral salmon calcitonin, salmon calcitonin nasal spray

Timeline

• Start date: 2005-10-01
• First posted: 2007-06-14
• Last updated: 2007-06-14

Locations

1 site across 1 country: Denmark