We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Oral Salmon Calcitonin in Human Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376311
Recruitment Status : Terminated
First Posted : September 14, 2006
Last Update Posted : September 14, 2006
Sponsor:
Collaborator:
Novartis
Information provided by:
Université Catholique de Louvain

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: oral salmon calcitonin Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis
Study Start Date : September 2002
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Lequesne's algofunctional index
  2. Biomarkers of joint metabolism

Secondary Outcome Measures :
  1. Safety and tolerance

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376311


Locations
Layout table for location information
Belgium
St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain
Brussels, Belgium, B-1200
Sponsors and Collaborators
Université Catholique de Louvain
Novartis
Investigators
Layout table for investigator information
Study Director: Daniel H Manicourt, MD, PhD Department of Rheumatology, University hospital St Luc, Brussels, Belgium
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00376311    
Other Study ID Numbers: Daniel H Manicourt
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: September 14, 2006
Last Verified: June 2002
Keywords provided by Université Catholique de Louvain:
Lequesne's algo-functional score
Biomarkers of joint metabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Calcitonin
Salmon calcitonin
 Calcitonin Gene-Related Peptide
Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents