Effects of Oral Salmon Calcitonin in Human Osteoarthritis

September 13, 2006 updated by: Université Catholique de Louvain

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1200
        • St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lequesne's algofunctional index
Biomarkers of joint metabolism

Secondary Outcome Measures

Outcome Measure
Safety and tolerance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Collaborators

Novartis

Investigators

  • Study Director: Daniel H Manicourt, MD, PhD, Department of Rheumatology, University hospital St Luc, Brussels, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

December 30, 2005

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 14, 2006

Study Record Updates

Last Update Posted (Estimate)

September 14, 2006

Last Update Submitted That Met QC Criteria

September 13, 2006

Last Verified

June 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Daniel H Manicourt

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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