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Effects of Oral Salmon Calcitonin in Human Osteoarthritis

This study has been terminated.
Sponsor:
Collaborator:
Novartis
Information provided by:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00376311
First received: December 30, 2005
Last updated: September 13, 2006
Last verified: June 2002
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Drug: oral salmon calcitonin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • Lequesne's algofunctional index
  • Biomarkers of joint metabolism

Secondary Outcome Measures:
  • Safety and tolerance

Estimated Enrollment: 54
Study Start Date: September 2002
Estimated Study Completion Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376311

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

No publications provided

ClinicalTrials.gov Identifier: NCT00376311     History of Changes
Other Study ID Numbers: Daniel H Manicourt
Study First Received: December 30, 2005
Last Updated: September 13, 2006
Health Authority: Belgium: Institutional Review Board

Keywords provided by Université Catholique de Louvain:
Lequesne's algo-functional score
Biomarkers of joint metabolism

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Calcitonin
Calcitonin Gene-Related Peptide
Salmon calcitonin
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014