Effects of Oral Salmon Calcitonin in Human Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00376311
• Other study ID #: Daniel H Manicourt
• Status: Terminated
• Phase: Phase 2
• First received: December 30, 2005
• Last updated: September 13, 2006
• Start date: September 2002
• Est. completion date: May 2004

Study information

• Verified date: June 2002
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.

Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.

Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• oral salmon calcitonin

Locations

Country	Name	City	State
Belgium	St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Novartis

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lequesne's algofunctional index
Primary	Biomarkers of joint metabolism
Secondary	Safety and tolerance