Effects of Oral Salmon Calcitonin in Human Osteoarthritis

• Status: Terminated
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Université Catholique de Louvain
• Collaborator: Novartis
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin; Salmon calcitonin

Criteria

Inclusion Criteria:

• radiographic OA according to the criteria of the American College of Rheumatology;

• morning joint stiffness between 15 and 30 minutes;

• pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;

• normal liver and kidney function tests;

• serum CRP levels < 10 mg/l

Exclusion Criteria:

• previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene

• crystal deposition diseases

• known hereditary or congenital defects

• clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases

• intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)